Multi-phase, mult-compartment capsular delivery apparatus and methods for using same

ABSTRACT

A multi-compartment capsule, comprising, a first receiving chamber comprising at least one ingredient having a first physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; and a second receiving chamber comprising at least one ingredient having a second physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; wherein said first physical state of said ingredient of said first receiving chamber being different from said second physical state of said ingredient of said second receiving chamber; and said ingredient of said first receiving chamber being different from said ingredient of said second receiving chamber.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/804,576, filed Mar. 19, 2004, and entitled “MULTI-COMPARTMENTCAPSULAR DELIVERY APPARATUS AND METHODS FOR USING THE SAME”, which is acontinuation-in-part of PCT/US/03/10816 filed Apr. 9, 2003, and entitled“MULTI-PHASE, MULTI-COMPARTMENT CAPSULAR SYSTEM”, the contents of whichare hereby incorporated by reference in their entirety. This applicationincorporates herein by reference U.S. Provisional Application Ser. No.60/371,448, filed Apr. 10, 2002, and entitled “INTEGRATED CAPSULEDELIVERY APPARATUS AND) METHOD.” This application further claims thebenefit of U.S. application Ser. No. 10/369,427, filed Feb. 18, 2003,entitled “MULTI-PHASE, MULTI-COMPARTMENT CAPSULAR DELIVERY APPARATUS ANDMETHODS FOR USING SAME,” which is hereby incorporated herein byreference. This application further claims the benefit of U.S.application Ser. No. 10/368,951, filed Feb. 18, 2003, entitled “PROCESSFOR ENCAPSULATING MULTI-PHASE, MULTI-COMPARTMENT CAPSULES”, which ishereby incorporated herein by reference. This application further claimsthe benefit of U.S. application Ser. No. 10/369,244, filed on Feb. 18,2003, and entitled “MULTI-PHASE, MULTI-COMPARTMENT CAPSULAR DELIVERYAPPARATUS FOR THERAPEUTIC COMPOSITIONS AND METHODS FOR USING SAME,”which is hereby incorporated herein by reference. This applicationfurther claims the benefit of U.S. application Ser. No. 10/369,247,flied Feb. 18, 2003, and entitled “PROCESS FOR ENCAPSULATINGMULTI-PHASE, MULTI-COMPARTMENT CAPSULES FOR THERAPEUTIC COMPOSITIONS,”which is hereby incorporated herein by reference.

BACKGROUND

1. The Field of the Invention

The present invention relates to delivery of active ingredients ormedicaments and, more particularly, to novel capsular delivery apparatusand methods for delivering one or more active ingredients or medicamentshaving diverse physical states (e.g., solid, liquid, gas or dispersion)into a single dosage, multi-compartment capsule.

The present invention further relates to methods for the administrationof a plurality of heterogeneous chemical and biological compounds toanimals and humans using a multicompartment delivery system fortreatment of different conditions or the same condition or diseases(different or same) in one or more organ systems.

2. Background of the Invention

As appreciated by those skilled in the art, the contemplation, design,testing and manufacture of chemicals and biomolecules for administrationto humans and animals, as nutritional or therapeutic agents, requires athorough integration of clinically contemplated delivery principles andmodalities. Chemicals and biomolecules that may be administered tohumans and animals are often referred to herein as “actives,” “activeingredients” or “medicaments,”

Oral administration has become one of the most frequent routes fordelivering one or more active ingredients or medicaments to the body.Active ingredients or medicaments, such as nutritional or therapeuticagents, may be orally administered in a variety of physical states(i.e., solid, liquid or gas). Tablets and capsules are generally themost common vehicle for the oral delivery of medicaments. Asappreciated, a tablet may be broadly characterized as a compressedpowder or granular solid. Prior to compression of the granular powdercomprising the medicament into tablet form, the presence of one or moreexcipients may be required. An excipient includes any inert substance(i.e., gum arabic, starch or the like) combined with a principalingredient to facilitate the preparation of an agreeable or convenientdosage form of the active or medicament. Functional characteristics ofexcipients may include, for example, disintegration, lubrication,appearance, palatability, shelf-stability or the like.

Those skilled in the art also developed capsules as a contrivance forcontaining a solid or liquid dosage form of a medicament. Traditionalcapsular embodiments include a first containment section referred to asa base, and a second containment section referred to as a cap. The twopieces of the capsule are usually formulated and designed in a mannersuch that the material to be encapsulated may be introduced into thebase section, whereas the open end of the cap section may becorrespondingly positioned over the open end of the base. The walls ofthe cap and base are generally in physical contact with one another toform a single internal cavity. A means for structurally sealing the capin relation to the base may also be incorporated during manufacture toinsure non-tampering of the capsule. In this regard, those skilled inthe art developed sealing technology which contemplates banding, heatfusion (spot-welding) and snap seals which utilize a “tongue and groove”scheme.

The outer walls of a capsule are preferably formed of a solubleingredient, such as, for example, gelatin (animal-based product),starch, hydrophillic polymer or hydroxypropyl methyl-cellulose (HPMC),which provides a barrier for containing the active ingredient ormedicament, in powder or liquid form, within the internal periphery ofthe capsule walls. Traditionally, hard gelatin capsules may bemanufactured by dipping plates of stainless steel pins into a pool ofgelatin solution. The pins are then removed from the gelatin and rotatedwhile the gelatin is dried in a kiln with forced, humidity-controlledair. Once dried, the gelatin capsules are typically stripped from thepins, trimmed to a suitable length and then joined together (e.g., baseand cap) and packaged for production use. With the advent of automatedencapsulation machinery, the responsibility to produce encapsulatedproducts shifted mainly to industrial manufacturers. Contemporaneouswith the development of the encapsulation industry, those skilled in theart have advanced the state of the encapsulation art. For example,several significant improvements in encapsulation technology have beenseen over the last forty years. These technological improvements haveincluded, for example, the development of soft elastic capsules,film-coating techniques, micro-encapsulation and multiple-compartmenttechnology.

Soft elastic capsules, often referred to as soft gelatin capsules, weredeveloped in an effort to provide means for encapsulating liquids andother medicaments which are typically poorly soluble in water. Inpreferred design, soft elastic capsules are made from a thicker and moreplastic gelatin having an increased flexibility due to the addition of apolyol, such as glycerin or sorbitol. The addition of such plasticizershas been found, however, to have the potential disadvantage ofincreasing the risk for microbial growth. Thus an antimicrobial, such asa paraben or sorbic acid, may be added to the soft elastic capsule shellin order to address any microbial concern.

Prior art film-coating techniques generally involve a plating process,whereby a thin, uniform film may be deposited onto the outer surface ofthe delivery vehicle (e.g., tablet or capsule). Several successivelayers may be deposited onto the outer surface of the vehicle, ifdesired, in an effort to facilitate various desirable properties. Forexample, sugar-coating, a precursor to film-coating, has been used bythose skilled in the art for more than one hundred years to make tabletsmore palatable. Other advantages or properties of film-coating mayinclude for example, but not by way of limitation, protection frommoisture, oxidation, controlling microbial contamination and inhibitingmodification of the chemical properties of the active ingredient. Asfurther appreciated by those skilled in the art, prior art film-coatingmay form an interfacial barrier between two chemicals or chemicalcompounds that might otherwise react when they come into contact.

Enteric coatings and sustained-release formulations are contemplated asvariations on prior art film-coating techniques. In particular, entericcoating describes a process where the delivery vehicle (e.g., tablet orcapsule) is coated with one or more layers of chemicals that aresomewhat resistant to extreme pH conditions. For example, conditions ofextremely low pH are commonly encounter in the stomach. Many activeingredients or medicaments are in the form of a pharmaceutical salt andthus highly susceptible to ionization in the presence of hydrogen ions.Thus, the presence of an enteric coating generally provides a level ofprotection as to degradation of the active ingredient or medicamentuntil transit from the stomach into the small intestine is accomplished.

Film coatings have also led to the development of delivery vehicles(e.g., tablets and capsules) having sustained-release properties.Mixtures of waxes, cellulose, silicone and similar resins have beenfound useful by those skilled in the art for creating-sustained releasecoatings. In principle, these prior art coatings function to delay therelease of the active ingredient or medicament to the targeted bodysystem, thereby facilitating a timed, absorption rate in the body.Furthermore, the entire daily dosage of an active or medicament may becontained in a single, sustained-release delivery vehicle (e.g., tabletor capsule), whereas the immediate absorption of the entire dosage couldpossibly lead to an overdosage of the medicament. Thus, by layeringquanta of medicament with differential coatings, the dosage undergoes acontrolled release over specified time period. The application ofsustained-release film coating technology therefore may inherentlyfacilitate the delivery of a total daily dosage amount of an active ormedicament to be released to the body in controlled increments.

Over the last several years, a considerable amount of attention has beenfocused on the further development of multi-compartment capsuletechnology for the delivery of therapeutic and diagnostic agents. Seriesformulations teach the use of membranes or other types of barriers tocordon a line of separate chambers within a single encapsulating shell.As appreciated, the purpose of such multi-compartment delivery devicesis the administration of multiple dosages. Moreover,multiple-compartment delivery mechanisms of the prior art were developedto circumvent or diminish the effects of harsh pH environments withinhumans. For example, the prior art contemplates a hard capsuleformulation which contains three different compartments of activemedicaments for administration to the vaginal and rectal areas. Inpreferred structure, the formulation outer, rapid-release layer maycontain an active medicament and excipient; the middle,intermediate-release layer may include a powder form of activemedicament; and the inner, slow-release layer may contain pellets orgranules of active medicament.

Also taught in the prior art are multi-compartment capsules havinggroups of spheroids with pH-dependent coatings which are encapsulatedwithin a hard gelatin shell and provided for treating female yeastinfection. The first spheroid is preferably uncoated and may be in apowder form; the second spheroid may contain a pH sensitive coat; andthe inner spheroid may include a pH insensitive coat.

In addition to pH-sensitive coatings, hydrogels and other gastricretention technologies have been developed by those skilled in the artin an effort to retard the progression of the delivery vehicle duringenteric transit. This retarding action, presumably, allows the fullamount of active medicament to be released and/or targeted to a specificarea of the gastrointestinal tract. Hydrogel and related gastricretention devices of the prior art generally rely upon the imbibing ofwater into a center core which is filled with cellulose or similar waterabsorbent material. In preferred operation, the material swells andreleases multiple compartments of active medicament. The concept ofusing bulk size to slow transit of single active medicament in a singlephysical state is thus appreciated.

In an effort to administer active ingredients or medicaments to aspecific location in the body to treat a specific disorder caused by aspecific pathogen, those skilled in the art have used targeted-releasesystems using multi-compartment capsular technology. For example, amethod for carrying out a triple therapy against the microorganismsHeliobacter pylori, a known infectious agent which is believed largelyresponsible for the development of gastric ulcer disease, was developedwhich comprises the steps of oral administration of a pharmaceuticaldosage form comprising an internal capsule placed inside an externalcapsule, wherein the external capsule comprises a soluble salt ofbismuth and a first antibiotic, and the internal capsule comprises asecond antibiotic. In addition, multi-compartmental capsules weredeveloped which combine a nutrient supplement with a viable direct-fedmicrobial (i.e., gastrointestinal microorganisms, including bacteria,live cell yeasts, fungi or a combination thereof) for the purpose oftreating livestock for feeding disorders and improving feed efficiency.

A disadvantage with prior art encapsulation technology is when the baseand corresponding cap of a capsule are joined, dead space volume istypically created within the internal periphery of the capsule. Internalcapsular dead space may be filed with an air bubble which may ultimatelyreact with one or more of the active ingredients or medicamentsintroduced within the capsule, thereby potentially degrading the qualityand effectiveness of the active ingredients.

Although the prior art discloses multiple compartment, capsular deliverytechnology, these manifestations generally includes one of twoapproaches. For example, one approach contemplates the introduction of asingle active or medicament into multiple capsular compartments to varythe temporal release of the medicament and ultimately the absorptionrate into the body. Another approach contemplates the introduction of aplurality of active ingredients or medicaments into differentcompartments of a single capsule for delivery to a specific area of thebody to treat a targeted illness or condition.

The use or contemplation of multiple-compartment capsular deliveryapparatus or methods which deliver different physical forms of the sameactive or medicament, or a variation in physical forms of differentactives or medicaments in a single dosage, however, has not heretoforebeen contemplated in the art. As appreciated by those skilled in theart, active ingredients or medicaments may take the physical form of asolid (e.g., pill, tablet, capsule (both hard and soft elastic), powder,granulation, flakes, troches (lozenges and pastilles), suppositories andsemi-solid ointments, pastes, emulsions and creams), a liquid (e.g.,solution, spirits, elixir, syrups, sprays and fluid extracts), a gas ora dispersion. A dispersion is a system in which a dispersed phase isdistributed through a continuous phase (e.g., aerosols (liquid or solidin gas), suspensions (solid in liquid), emulsion (liquid in liquid),foam (gas in liquid), solid foam (solid in gas) or gel (liquid or solidin solid)). Dispersions can be classified as molecular, colloidal andcoarse, depending on size. In many circumstances, however, the differentphysical forms or phases of more than one active ingredient ormedicament may not be suitably combined or mixed together withoutaltering the individual desirable properties of the active ingredient ormedicament. For example, although it would be possible and desirable toformulate a dispersion by combining a first active ingredient in thesolid state with a second active ingredient that exists as a liquid,adverse chemical interactions between the active ingredients mayadversely affect various characteristics of the ingredients, includingbut not limited to, their shelf lives. The resulting chemicaldecomposition—and the potential formation of any unwanted sideproducts—could result in diminished drug potency or even toxicity to apatient.

Additionally, the physical properties of crystalline active ingredientscould be drastically altered in scenarios where it is desirable toco-administer a crystalline active ingredient with a liquid orsemi-liquid different active ingredient. In this context, the control ofphysical properties such as active ingredient dissolution rate andsolubility is often a critical factor in determining the overallbioavailability of the active ingredient. It is well established in theart that different polymorphs or solvates of the same crystalline activeingredient exhibit dramatically different solubility and dissolutionrates. Thus, combining a crystalline active agent with a liquid orsemi-liquid active agent could give rise to an equilibrium betweenconcentrations of different polymorphs and/or solvates of thecrystalline active ingredient, and thereby frustrate efforts attailoring an active ingredient mixture to its intended purpose as amedicament.

Another shortcoming with co-administering plural active ingredients indifferent physical forms in an intimate mixture is the potential foradverse in vivo drug-drug interactions upon administration. The desireto co-administer these active ingredients would be offset by the oneactive ingredient, for example as in a liquid or semi-liquid (e.g., apaste, solution, or syrup) form, becoming rapidly available. In thiscontext, the active ingredient may adversely react with aco-administered drug, for example a less bioavailable solid orsemi-solid, in a physiological environment. Thus, the true therapeuticbenefit resulting from the pharmacological effects of the individualactive agents may never be realized. It would be desirable toco-administer plural active ingredients while insuring against thepotential of such harmful drug-drug interactions.

Providing active ingredients or medicaments in separate capsules mayalso be undesirable in the context of patient compliance. Geriatric andpediatric populations in particular disfavor the handling andconsumption of multiple capsules of active ingredients. Patientcompliance is essential in maintaining patient health in many dosageregimens. For example, deviations from accurate dosing and consistentconsumption of immunosuppressant therapies can result in severe or evenlethal consequences for a patient. Providing combined dosages of activeingredients would result in fewer capsules a patient or consumer wouldhave to take, and thereby contribute to an overall increase incompliance.

Therefore, it would be desirable to provide a multi-compartment capsulardelivery apparatus and methods that provide active ingredients ormedicaments having diverse physical properties (e.g., solid, liquid, gasor dispersion), which mayor may not be properly combined or storedtogether into a unitary structure (i.e., multi-compartment capsule) forusage in a single dosage form. The present invention, in overcoming theshortcomings of the prior art, satisfies these and other objectives.

The art and practice of pharmacy can be divided into four distinctdivisions. Pharmacology is the study of interactions occurring betweenthe pharmacologic agent, or medicament and specific targeted cells inthe body. More specifically, the interaction between an active agent anda cellular receptor along with the resulting change in cell physiologyis examined. Medicinal chemistry is largely concerned with theidentification of naturally occurring and synthetic compounds whichpossess medicinal characteristics.

Pharmacotherapeutics is the holistic application of pharmacy practice tospecific pathologies, illnesses, and other body functions. Finally,Pharmaceutical science ascertains or regulates the composition ofmedicinal substances, and is largely directed to the development of newmechanisms for delivering chemicals and biomolecules into animals andhumans. A subcategory of pharmaceutical science is calledpharmacokinetics and sometimes generally referred to asbiopharmaceutics.

A.D.M.E. is an acronym often used to describe the four essentialcomponents to pharmaceutical science: absorption, distribution,metabolism, and elimination, respectively. One way to differentiatebetween pharmacology and pharmaceutical science is that the former isprimarily concerned with the effect of the medicament on the body,whereas, the latter is primarily concerned with the delivery andtime-course of the medicament on its journey through the body.

In clinical applications, chemicals and biomolecules are often referredto as active ingredients or medicaments. Medicaments may include“pharmaceuticals, nutraceuticals, biotechnicals, vitamins, minerals anddietary supplements.” Oral administration is the most frequent route fordelivery of medicaments. Medicaments may be orally administered in avariety of physical states, including, solid, liquid, dispersion, andgaseous forms. As appreciated, tablets and capsules are the most commonvehicle for oral delivery of medicaments.

Frequently, a medical or surgical patient may receive a plurality ofconcurrent medicaments. Data has been accumulated to demonstrate thatpatients undergoing a surgical procedure may receive ten (10) or moremedicaments during the surgery and the resulting surgical recoveryperiod. Some patients who have undergone organ transplantation or whohave contracted human immunodeficiency virus (HIV) may receive three (3)or more medicaments which require multiple administrations per day. HIVpatients often receive many more than three (3) medicaments. Thesemedicaments may be necessary for the treatment of several conditionsoccurring in a plurality of organ systems or they may be necessary totreat a single condition or some combination thereof.

In some cases, it may be desirous to combine a plurality of medicamentsbecause of a synergistic interaction between a plurality of medicaments.This synergy may enhance the efficacy of one or more of the medicaments.Medicaments may be combined to increase the intensity of response orefficacy. A plurality of medicaments, in combination, may be homergic(i.e., elicit the same quality of effect). In many cases, a plurality ofhomergic medicaments may also be homo dynamic (i.e., interact with thesame receptor). A plurality of homergic medicaments may be additive,supra-additive and infra-additive. A plurality of combined medicamentswhich do not produce the same quality of response may be called,heterergic. When heterergy is found to be a positive effect (i.e., atleast one medicament enhances the response to another medicament), thismay be called synergism and is sometimes called synergy.

In further cases, it maybe desirous to combine a plurality ofmedicaments to decrease their individual dosages and possibility fortoxicity. It may also be desirous to combine a plurality of medicamentsto target the treatment of a disease, illness or condition fromdivergent angles. It may be desirous to combine a plurality ofmedicaments to minimize the side effects and adverse effects of one ormore medicaments. It may be still further desirous to combine aplurality of medicaments to alter the pharmacokinetic characteristics ofone or more medicaments. For example, alterations in the absorption,distribution, metabolism or elimination of one or more medicaments.

Fixed combinations of a plurality of medicaments have been generallydisfavored due to any number of perceived disadvantages. Thesedisadvantages may include, for example: (1) complicating theinterpretation of safety and efficacy in therapeutic regimens, (2) theremay be inter-patient differences to fixed combinations, (3) there may bedifficulties in dosage titration, and (4) the delivery platforms forfixed combinations have generally been found to be uneconomical toproduce.

On the other hand, fixed combinations of a plurality of medicaments maylead to several therapeutic advantages, including, for example, but notby way of limitation: (1) increasing patient compliance with therapy,(2) increasing efficacy by optimizing timing of medicaments, (3)minimization of side effects and adverse effects, (4) enhancement ofpharmacokinetic characteristics of one or more medicaments in a fixedcombination, (5) increased patient quality of life, (6) optimization ofinstitutional resources by minimizing the amount of medicamentadministrations, and (7) minimizing patient length of stay ininstitutional facilities by optimizing therapy.

Prior art therapeutic technologies contain isolated examples ofpharmaceutical formulations containing fixed combinations ofmedicaments. However, therapeutic technologies of the prior art teach afixed combination, wherein a plurality of medicaments are placed into asingle receiving chamber in the delivery formulation (i.e. no separationbetween the plurality of medicaments).

In view of the state of the technology as it exists today, generally,therapeutic apparatus and methods are needed to provide a plurality ofmedicaments for medical and surgical conditions, as well as maintenanceof normal health function for delivery to animals and humans using amulti-chambered delivery apparatus. Such apparatus and methods fordelivering a plurality of medicaments to animals and humans using amulti-chambered delivery apparatus are contemplated herein.

BRIEF SUMMARY AND OBJECTS OF THE INVENTION

In view of the foregoing, it is a primary object of the presentinvention to provide novel integrated capsule delivery apparatus andmethods for delivering diverse physical states (e.g., solid, liquid, gasor dispersion) of a single active ingredient or medicament, or aplurality of active ingredients or medicaments, in a single dosage form,wherein at least two of the active ingredients or medicaments havephysical states that differ.

It is also an object of the present invention to provide novelintegrated capsule delivery apparatus and methods which facilitatevarious desirable properties including, for example, controllingtime-release of key active ingredients or medicaments, prolongingshelf-life of the active ingredients or medicaments, improvingpalatability, reducing overall production costs and, accordingly,reducing the number of capsules consumed by a patient or consumer asnutritional or therapeutic agents.

Further, it is an object of the present invention to provide novelintegrated capsule delivery apparatus and methods for delivering one ormore active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof) in the form of a single dosage, multi-compartmentcapsule having one or more active ingredients in a primary capsule, andone or more active ingredients introduced into a secondary smallercapsule having a size sufficient for being selectively positionablewithin the primary capsule, wherein the active ingredient(s) within theprimary capsule comprises a physical state (e.g., solid, liquid, gas ordispersion) that is different from the physical state of the activeingredient(s) in the secondary capsule.

It is an additional object of the present invention to provide novelintegrated capsule delivery apparatus and methods for delivering one ormore active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof) in the form of a single dosage, multi-compartmentcapsule having one or more active ingredients in a primary capsule andthe same active ingredient(s) introduced into a smaller secondarycapsule having a size sufficient for being positionable within theprimary capsule, wherein the active ingredient(s) in the primary capsulecomprises a physical state (e.g., solid, liquid, gas or dispersion)different from the active ingredient(s) in the secondary capsule.

It is a further object of the present invention to provide novelintegrated capsule delivery apparatus and methods for delivering one ormore active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof) in the form of a single dosage, multi-compartmentcapsule wherein at least one of the primary and secondary capsulesinclude a time-release coating for controlling the release of the activeingredient(s) contained therein.

It is also another object of the present invention to provide novelintegrated capsule delivery apparatus and methods for delivering one ormore active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof) in the form of a single dosage, multi-compartmentcapsule having, one or more active ingredients in the capsular body,wherein the capsule includes a longitudinally extending body and atleast one dividing wall formed along a length of the extending body toform a first chamber and an opposing second chamber within the capsularbody and introducing at least one active ingredient or medicament havinga first physical state into the first chamber and at least one activeingredient or medicament having a second physical state into a secondchamber, whereas the physical state (e.g., solid, liquid, gas ordispersion) of the ingredient(s) in the first chamber is different fromthe physical state of the ingredient(s) in the second chamber.

It is an additional object of the present invention to provide novelintegrated capsule delivery apparatus and methods for delivering one ormore active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof) in the form of a single dosage, multi-compartmentcapsule having a longitudinally extending body and one or more dividingwalls disposed along the length of the longitudinally extending body ofthe capsule, wherein the capsule and one or more of the dividing wallscontained therein may include time-release coatings for controlling therelease of the active ingredients or medicaments contained therein,respectively.

It is a further object of the present invention to provide novelintegrated capsule delivery apparatus and methods for delivering one ormore active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof) in the form of a single dosage, multi-compartmentcapsule having a plurality of active ingredients or medicaments havingthe physical form of a solid (e.g., pill, tablet, capsule (both hard andsoft elastic), powder, granulation, flakes, troches (lozenges andpastilles), suppositories and semi-solid ointments, pastes, emulsionsand creams), a liquid (e.g., solution, spirits, elixir and fluidextracts), a gas or a dispersion (e.g., aerosols (liquid or solid ingas), suspensions (solid in liquid), emulsion (liquid in liquid), foam(gas in liquid), solid foam (solid in gas) or gel (liquid or solid insolid), wherein the physical form of the active ingredients differbetween a primary and secondary capsule, and between one or moredividing wails disposed in spaced-apart relationship along the length ofa longitudinally extending capsular body.

It is a still further object of the present invention to provide novelintegrated capsule delivery apparatus and methods for delivering one ormore active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof) in the form of a single dosage, multi-compartmentcapsule, wherein an encapsulation process comprises the steps of: (1)providing a capsule comprising a first end, a second end, alongitudinally extending body having a length disposed between the firstand second ends, and a plurality of dividing walls spaced apart alongthe length of the extending body, wherein the dividing walls form aplurality of receiving chambers; (2) introducing at least one activeingredient having a first physical state into a first receiving chamber;(3) introducing at least one active ingredient having a second physicalstate into a second receiving chamber; (4) introducing at least oneactive ingredient having a third physical state into a third receivingchamber, wherein the physical states of at least two of the activeingredients introduced into the first, second or third receivingchambers differ; and (5) sealing the first and second ends of saidcapsule.

Additionally, it is an object of the present invention to provide novelintegrated capsule delivery apparatus and methods for delivering asingle dosage, multi-compartment capsule comprising a capsular base andcap configuration, wherein the size and shape of the cap, relative toits sealing relationship with the base, generally eliminates orsubstantially reduces any potential dead space volume within theinternal periphery of the capsule, thereby functionally negating theopportunity for reaction between an air bubble and one or more activeingredients introduced into the capsule and, accordingly, improvingstability of the capsular ingredient(s).

Consistent with the foregoing objects, and in accordance with theinvention as embodied and broadly described herein, one presentlypreferred embodiment of the novel integrated capsule delivery apparatusand methods of the present invention comprises a multi-compartmentcapsule including a primary capsule and a secondary capsule selectivelypositionable within an internal periphery of the primary capsule. Thesecondary capsule may include a base, a corresponding cap and one ormore receiving chambers. Each of the receiving chambers of the secondarycapsule may be formed having an internal periphery sufficient forreceiving at least one active ingredient or medicament (e.g.,pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof) therein. Similarly, theprimary capsule may be formed having a base, a corresponding cap and oneor more receiving chambers. The receiving chambers of the primarycapsule may be formed having an internal periphery sufficient forreceiving the secondary capsule and one or more active ingredients ormedicaments (e.g., pharmaceutical, biotechnical, nutraceutical, vitamin,dietary supplement, mineral or combination thereof) having a physicalstate (i.e., solid, liquid, gas or dispersion) different from thephysical state of the active ingredient(s) housed within the receivingchamber of the secondary capsule.

As further contemplated herein, a multi-compartment capsule is providedcomprising a base, a corresponding cap and one or more dividing wallspositionable between the base and the cap. Structurally, the size, shapeand positioning of the dividing walls relative to the base andcorresponding cap facilitates the formation of at least two, independentand separate receiving chambers. Each of the receiving chambers havingan internal periphery sufficient for receiving one or more activeingredients or medicaments (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) therein. In preferred design, the physical state (e.g., solid,liquid, gas or dispersion) of the active ingredient(s) in the firstreceiving chamber is different from the physical state of the activeingredient(s) in the second receiving chamber. After introducing one ormore active ingredients or medicaments into each receiving chamber, thecap may be selectively positioned in sealing relationship with the baseto form one presently preferred embodiment of the single, dosagemulti-compartment capsule.

One presently preferred embodiment of an encapsulation process forforming a multi-compartment capsule may comprise the steps of: (1)providing a primary capsule having a base, a corresponding cap and areceiving chamber; (2) providing a secondary capsule having a base, acorresponding cap and a receiving chamber; (3) introducing at least oneingredient or medicament (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) having a first physical state (e.g., solid, liquid, gas ordispersion) into at least a portion of the receiving chamber of thesecondary capsule and selectively positioning the cap in sealingrelationship with the base; (4) introducing at least one ingredient ormedicament (e.g., pharmaceutical, biotechnical, nutraceutical, vitamin,dietary supplement, mineral or combination thereof) having a secondphysical state (e.g., solid, liquid, gas or dispersion) into at least aportion of the receiving chamber of the primary capsule, wherein thefirst physical state of the ingredient(s) in the secondary capsule isdifferent from the second physical state of the ingredient(s) in theprimary capsule; and (5) introducing the secondary capsule into at leasta portion of the receiving chamber of the primary capsule andselectively positioning the cap in sealing relationship with the base toform a single dosage multi-compartment capsule.

In alternate presently preferred embodiments of the present invention, atertiary capsule comprising a base, a corresponding cap and a receivingchamber having an internal periphery sufficient for receiving one ormore active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof) may be selectively introduced within an internalperiphery of at least one receiving chamber of the secondary capsule.After the introduction of at least one active ingredient into one ormore receiving chambers of a tertiary capsule pursuant to anencapsulation process of the present invention, the cap of the tertiarycapsule may be selectively positioned in sealing relationship with thebase and then introduced into at least a portion of the internalperiphery of the secondary capsule, together with one or more activeingredients therein. It is contemplated herein that at least two of theactive ingredients introduced within the receiving chambers of theprimary, secondary and tertiary capsules, respectively, comprise atleast two different physical states (e.g., solid, liquid, gas ordispersion).

In preferred structural design, the primary capsule may comprise a caphaving a generally U-shaped configuration adapted to provide a sealingrelationship when engaging the corresponding base, thereby reducing deadspace volume in the internal periphery of the cap and receiving chamberof the base. A cap having a configuration adapted to generally eliminateor substantially reduce potential dead space volume of the cap andreceiving chamber of the base may, accordingly, function to negate thepotential for a reaction between an air bubble and one or more activeingredient(s) introduced into the base of the primary capsule.

Alternatively, a multi-compartment capsule of the present invention mayinclude the introduction of a filling material into the cap of theprimary capsule, the cap having a general cylindrical configurationadapted to provide a sealing relationship when engaging thecorresponding base. An amount of filling material may be introduced intoat least a portion of the internal periphery of the cap to fill, eitherpartially or completely, the inner volume of the cap, thereby reducingthe dead space volume in the cap and the internal periphery of thereceiving chamber of the base. In this regard, the introduction of afilling material relative to the internal periphery of the cap maygenerally eliminate or substantially reduce the potential dead spacevolume, thus functionally negating the potential for a reaction betweenan air bubble and one or more active ingredient(s) introduced into thebase of the primary capsule.

The primary, secondary or tertiary capsules, in accordance with thepresent invention, may be formed having the same or different colors.Moreover, the base and corresponding cap of a single capsule may beformed having different colors in an effort to enhance the aesthetics ofthe capsule to the consumer. In one presently preferred embodiment of amulti-compartment capsule of the present invention, the dosage may bebanded, sealed or easily dividable in a contact area of the primary andsecondary capsules or the sealing band may be color-coded to assist inbranding, if desired.

It is further contemplated herein that a multi-compartment capsule ofthe present invention may comprise component parts of the capsule havingvarious time-release coatings to facilitate the release and ultimatelythe absorption of those active ingredients introduced into the differentreceiving chambers of the multi-compartment capsule to release atdifferent release rates. In particular, a primary capsule may be formedhaving a conventional time-release coating that dissolves and releasesthe active ingredient(s) contained therein before the timed-release ofthe active ingredient(s) contained within a secondary capsule. Likewise,the dividing walls disposed within the internal periphery of the base ofa capsule may be formed having conventional time-release coatings thatdissolve and release the active ingredients within each receivingchamber defined by the dividing walls at different rates, therebydelivering the active ingredients or medicaments contained within amulti-compartment capsule at different rates. Certain active ingredientsor medicaments may, therefore, be delivered at a selected interval,while other ingredients may be released at a later interval. In thisway, the novel design of the multi-compartment capsules of the presentinvention may facilitate precision delivery of active ingredients totargeted areas of the consumer.

Still further, a primary object of the present invention is to providenovel delivery apparatus and methods for affecting multiple organsystems in animals or humans using a plurality of medicaments deliveredby a pharmaceutical formulation comprising a multi-chambered apparatus.Accordingly, the present invention provides novel delivery apparatus andadministration techniques or methods aimed at affecting multiple organsystems in an animal or human using a plurality of medicaments. Adelivery apparatus may be in any multi-chambered apparatus, butpreferably in a capsular formulation. Thus, a plurality of medicamentsmay be encapsulated and stored separately within a larger capsule untilthe time of ingestion, consumption, or the like. Upon consumption, thecapsule walls of one or more dividing walls of a capsule may dissolve torelease their contents. Different methods of encapsulation may be usedto deliver their respective contents, including but not limited to,dissolution, melting, ablation or biodegradation of the encapsulatingwall. In certain embodiments and as contemplated herein, the medicamentsretained in the multicompartment capsule may actually diffuse throughone or more of the encapsulating walls.

In one embodiment of the present invention there is a multi compartmentcapsule, comprising a first receiving chamber comprising at least oneingredient having a first physical state, wherein said ingredient isselected from the group consisting of a nutraceutical, a vitamin, adietary supplement and a mineral; and a second receiving chambercomprising at least one ingredient having a second physical state,wherein said ingredient is selected from the group consisting of anutraceutical, a vitamin, a dietary supplement and a mineral; said firstphysical state of said ingredient of said first receiving chamber beingdifferent from said second physical state of said ingredient of saidsecond receiving chamber.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, further comprising a baseand a corresponding cap, wherein said cap is configured to provide asealing relationship when engaging said base.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said cap comprises aconfiguration adapted to reduce dead volume space within said firstreceiving chamber.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, further comprising a fillingmaterial introduced into said cap to reduce dead volume space withinsaid first receiving chamber.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said fillingmaterial is selected from the group consisting of gelatin, starch,casein, chitosan, soya bean protein, safflower protein, alginates,gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinatedgelatin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropylmethyl cellulose, oleoresin, polyvinylacetate-phtalate, polymerisates ofacrylic or methacrylic esters and combinations thereof.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said first receivingchamber comprises no dead volume space.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said physical, stateof said ingredient in said first receiving chamber is selected from thegroup consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said physical stateof said ingredient in said second receiving chamber is selected from thegroup consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said solid isselected from the group consisting of a pill, a tablet, a capsule, apowder, granulation, flakes, a troche, a suppository, an ointment, apaste, an emulsion and a cream.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said liquid isselected from the group consisting of a solution, a spirit, an elixir, aspray, a syrup and a fluid extract.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said dispersion isselected from the group consisting of an aerosol, a suspension, anemulsion, a foam, a solid foam and a gel.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said first receivingchamber comprises a time-release coating.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said secondreceiving chamber comprises a time-release coating.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said time-releasecoating of said second receiving chamber is different from saidtime-release coating of said primary capsule.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, further comprising a thirdreceiving chamber comprising at least one ingredient.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredient insaid third receiving chamber is selected from the group consisting of anutraceutical, a vitamin, a dietary supplement and a mineral.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredient insaid third receiving chamber comprises a physical state selected fromthe group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said third receivingchamber comprises a time-release coating.

In another embodiment of the present invention, there is amulti-compartment capsule, comprising a primary capsule comprising atleast one ingredient having a first physical state, wherein saidingredient is selected from the group consisting of a nutraceutical, avitamin, a dietary supplement and a mineral; a secondary capsulecomprising at least one ingredient having a second physical state,wherein said ingredient is selected from the group consisting of anutraceutical, a vitamin, a dietary supplement and a mineral; said firstphysical state of said ingredient of said primary capsule beingdifferent from said second physical state of said ingredient of saidsecondary capsule; and said primary capsule comprising an internalperiphery sufficient for receiving said ingredient and said secondarycapsule therein.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said primary capsulefurther comprises a base and a corresponding cap, wherein said cap isconfigured to provide a sealing relationship when engaging said base.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said primary capsulecomprises no dead volume space.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said first physicalstate of said ingredient in said primary capsule is selected from thegroup consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said second physicalstate of said ingredient in said secondary capsule is selected from thegroup consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said primary capsulecomprises a time-release coating.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said secondarycapsule comprises a time-release coating.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said time-releasecoating of said secondary capsule is different from said time-releasecoating of said primary capsule.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said third receivingchamber comprises a time-release coating.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said primary capsuleis formed of a material selected from the group consisting of gelatin,starch, casein, chitosan, soya bean protein, safflower protein,alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin,succinated gelatin, cellulosephtalate-acetate, oleoresin,polyvinylacetate, hydroxypropyl methyl cellulose, polymerisates ofacrylic or methacrylic esters, polyvinylacetate-phtalate andcombinations thereof.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said primary capsulefurther comprises a soft elastic capsule formed of a material selectedfrom the group consisting of glycerin and sorbitol.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said soft elasticcapsule includes an antimicrobial selected from the group consisting ofparaben and sorbic acid.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said secondarycapsule is formed of a material selected from the group consisting ofgelatin, starch, casein, chitosan, soya bean protein, safflower protein,alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin,succinated gelatin, cellulosephtalate-acetate, oleoresin,polyvinylacetate, hydroxypropyl methyl cellulose, polymerisates ofacrylic or methacrylic esters, polyvinylacetate-phtalate andcombinations thereof.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredientintroduced in said primary capsule comprises a moisture content in therange of about 0% to 6% by weight.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredientintroduced in said secondary capsule comprises a moisture content in therange of about 0% to 6% by weight.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said primary andsecondary capsules contain at least one pharmaceutically acceptablelubricant in the range of about 0% to 10% by weight.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said lubricant isselected from the group consisting of aluminiumstearate,calciumstearate, magnesiumstearate, tinstearate, talc, sodium laurylsulfate, lecithins, mineral oils, stearic acid, silicones and mixturesthereof.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said primary andsecondary capsules have different colors.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said primary capsuleis formed having a first color.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said secondarycapsule is formed having a second color different from said first colorof said primary capsule.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said capsule furthercomprises a base and a corresponding cap, wherein said cap is configuredto provide a sealing relationship when engaging said base.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said base and saidcap are formed having different colors.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said sealingrelationship between said base and corresponding cap comprises no deadvolume space.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said physical stateof said ingredient in said first receiving chamber is selected from thegroup consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said physical stateof said ingredient in said second receiving chamber capsule is selectedfrom the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said capsulecomprises a time-release coating.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said dividing wallcomprises a time-release coating.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said time-releasecoating of said dividing wall is different from said time-releasecoating of said capsule.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said third receivingchamber comprises a time-release coating.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said capsule isformed of a material selected from the group consisting of gelatin,starch, casein, chitosan, soya bean protein, safflower protein,alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin,succinated gelatin, cellulosephtalate-acetate, oleoresin,polyvinylacetate, hydroxypropyl methyl cellulose, polymerisates ofacrylic or methacrylic esters, polyvinylacetate-phtalate andcombinations thereof.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said capsule furthercomprises a soft elastic capsule formed of a material selected from thegroup consisting of glycerin and sorbitol.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said dividing wallis formed of a material selected from the group consisting of gelatin,starch, casein, chitosan, soya bean protein, safflower protein,alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin,succinated gelatin, cellulosephtalate-acetate, oleoresin,polyvinylacetate, hydroxypropyl methyl cellulose, polymerisates ofacrylic or methacrylic esters, polyvinylacetate-phtalate andcombinations thereof.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredientintroduced in said first receiving chamber comprises a moisture contentin the range of about 0% to 6% by weight.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredientintroduced in said second receiving chamber comprises a moisture contentin the range of about 0% to 6% by weight.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said capsulecontains at least one pharmaceutically acceptable lubricant in the rangeof about 0% to 10% by weight.

In another embodiment of the present invention there is, anencapsulation process for forming a multi-compartment capsule, saidprocess comprising the steps of providing a primary capsule having abase and a cap; providing a secondary capsule having a base and a cap;introducing at least one ingredient having a first physical state intosaid secondary capsule, wherein said ingredient introduced into saidprimary capsule is selected from the group consisting of anutraceutical, a vitamin, a dietary supplement and a mineral;positioning said cap of said secondary capsule in sealing relationshipwith said base; introducing at least one ingredient having a secondphysical state into said primary capsule, wherein said ingredientintroduced into said primary capsule is selected from the groupconsisting of a nutraceutical, a vitamin, a dietary supplement and amineral; and wherein said first physical state of said ingredient ofsaid secondary capsule is different from said second physical state ofsaid ingredient of said primary capsule; introducing said secondarycapsule into said base of said primary capsule; and positioning said capof said primary capsule in sealing relationship with said base.

In another embodiment of the present invention there is, anencapsulation process as defined above, further comprising the step ofreducing dead volume space within said primary capsule.

In another embodiment of the present invention, an encapsulation processas defined above, further comprising the step of introducing a fillingmaterial into said cap of said primary capsule to reduce dead volumespace.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said filling material isselected from the group consisting of gelatin, starch, casein, chitosan,soya bean protein, safflower protein, alginates, gellan gum,carrageenan, xanthan gum, phtalated gelatin, succinated gelatin,cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methylcellulose, oleoresin, polyvinylacetate-phtalate, polymerisates ofacrylic or methacrylic esters and combinations thereof.

In another embodiment of the present invention, an encapsulation processas defined above, wherein said cap of said primary capsule comprises aconfiguration sufficient for reducing dead volume space within theprimary capsule.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said physical state ofsaid ingredient in said primary capsule is selected from the groupconsisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said physical state ofsaid ingredient in said secondary capsule is selected from the groupconsisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredientintroduced into said primary capsule is the same as said ingredientintroduced into said secondary capsule.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said primary capsulecomprises a time-release coating.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said secondary capsulecomprises a time-release coating.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said time-releasecoating of said secondary capsule is different from said time-releasecoating of said primary capsule.

In another embodiment of the present invention, there is anencapsulation process as defined above, further comprising the steps ofproviding a tertiary capsule having a base and a cap; introducing atleast one ingredient having a third physical state into said tertiarycapsule; positioning said cap of said secondary capsule in sealingrelationship with said base; and introducing said tertiary capsule intosaid base of said secondary capsule.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredient in saidtertiary capsule is selected from the group consisting of anutraceutical, a vitamin, a dietary supplement and a mineral.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredient in saidtertiary capsule comprises a physical state selected from the groupconsisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said tertiary capsulecomprises a time-release coating.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said primary capsule isformed of a material selected from the group consisting of gelatin,starch, casein, chitosan, soya bean protein, safflower protein,alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin,succinated gelatin, cellulosephtalate-acetate, polyvinylacetate,hydroxypropyl methyl cellulose, oleoresin, polymerisates of acrylic ormethacrylic esters, polyvinylacetate-phtalate and combinations thereof.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said primary capsulefurther comprises a soft elastic capsule formed of a material selectedfrom the group consisting of glycerin and sorbitol.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said secondary capsuleis formed of a material selected from the group consisting of gelatin,starch, casein, chitosan, soya bean protein, safflower protein,alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin,succinated gelatin, cellulosephtalate-acetate, polyvinylacetate,hydroxypropyl methyl cellulose, oleoresin, polymerisates of acrylic ormethacrylic esters, polyvinylacetate-phtalate and combinations thereof.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said secondary capsulefurther comprises a soft elastic capsule formed of a material selectedfrom the group consisting of glycerin and sorbitol.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredientintroduced in said primary capsule comprises a moisture content in therange of about 0% to 6% by weight.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredientintroduced in said secondary capsule comprises a moisture content in therange of about 0% to 6% by weight.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said primary andsecondary capsules contain at least one pharmaceutically acceptablelubricant in the range of about 0% to 10% by weight.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said lubricant isselected from the group consisting of aluminiumstearate,calciumstearate, magnesiumstearate, tinstearate, talc, sodium laurylsulfate, lecithins, mineral oils, stearic acid, silicones andcombinations thereof.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said primary andsecondary capsules are formed having different colors.

In another embodiment of the present invention, there is anencapsulation process for forming a multi-compartment capsule, saidprocess comprising the steps of providing a capsule comprising a cap, abase configured having a longitudinally extending body including alength and at least one dividing wall formed along said length of saidextending body, said dividing wall adapted to form a first receivingchamber and a second receiving chamber; introducing at least oneingredient having a first physical state into said second receivingchamber, wherein said ingredient introduced into said primary capsule isselected from the group consisting of a nutraceutical, a vitamin, adietary supplement and a mineral; introducing at least one ingredienthaving a second physical state into said first receiving chamber,wherein said ingredient introduced into said primary capsule is selectedfrom the group consisting of a nutraceutical, a vitamin, a dietarysupplement and a mineral, and wherein said first physical state of saidingredient of said second receiving chamber being different from saidsecond physical state of said ingredient of said first receivingchamber; and positioning said cap in sealing relationship with saidbase.

In another embodiment of the present invention, there is anencapsulation process as defined above, further comprising the step ofreducing dead volume space within said primary capsule.

In another embodiment of the present invention, there is anencapsulation process as defined above, further comprising the step ofintroducing a filling material into said cap to reduce said dead volumespace.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said filling material isselected from the group consisting of gelatin, starch, casein, chitosan,soya bean protein, safflower protein, alginates, gellan gum,carrageenan, xanthan gum, phtalated gelatin, succinated gelatin,cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methylcellulose, oleoresin, polyvinylacetate-phtalate, polymerisates ofacrylic or methacrylic esters and combinations thereof.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said cap comprises aconfiguration sufficient for reducing dead volume space within saidcapsule.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said physical state ofsaid ingredient in said receiving chamber is selected from the groupconsisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said physical state ofsaid ingredient in said second receiving chamber is selected from thegroup consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said first receivingchamber comprises a time-release coating.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said second receivingchamber comprises a time-release coating.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said time-releasecoating of said second receiving chamber is different from saidtime-release coating of said first receiving chamber.

In another embodiment of the present invention, there is anencapsulation process as defined above, further comprising the steps ofpositioning a second dividing wall along said length of said extendingbody, said second dividing wall adapted to form a third receivingchamber; and introducing at least one ingredient having a third physicalstate into said third receiving chamber.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredient in saidthird receiving chamber is selected from the group consisting of anutraceutical, a vitamin, a dietary supplement and a mineral.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredient in saidthird receiving chamber comprises a physical state selected from thegroup consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said dispersion isselected from the group consisting of an aerosol, a suspension, anemulsion, a foam, a solid foam and a gel.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said third receivingchamber comprises a time-release coating.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said capsule is formedof a material selected from the group consisting of gelatin, starch,casein, chitosan, soya bean protein, safflower protein, alginates,gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinatedgelatin, cellulosephtalate-acetate, polyvinyl acetate, hydroxypropylmethyl cellulose, oleoresin, polymerisates of acrylic or methacrylicesters, polyvinylacetate-phtalate and combinations thereof.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said capsule furthercomprises a soft elastic capsule formed of a material selected from thegroup consisting of glycerin and sorbitol.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said primary andsecondary capsules contain at least one pharmaceutically acceptablelubricant in the range of about 0% to 1.0% by weight.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said lubricant isselected from the group consisting of aluminiumstearate,calciumstearate, magnesiumstearate, tinstearate, talc, sodium laurylsulfate, lecithins, mineral oils, stearic acid, silicones andcombinations thereof.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said base and said capof said capsule are formed having different colors.

In another embodiment of the present invention, there is anencapsulation process as defined above, further comprising the step ofintroducing two or more dividing walls adapted to form a plurality ofreceiving chambers into said base of said capsule.

In another embodiment of the present invention, there is anencapsulation process as defined above, further comprising the step ofintroducing a capsule into one of said plurality of receiving chambers.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said capsule maycomprise a multi-compartment capsule.

In another embodiment of the present invention, there is amulti-compartment capsule, comprising a first receiving chambercomprising at least one ingredient having a first physical state; and asecond receiving chamber comprising at least one ingredient having asecond physical state, wherein said first physical state of saidingredient of said first receiving chamber being different from saidsecond physical state of said ingredient of said second receivingchamber.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said first receivingchamber comprises no dead space.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said cap isconfigured to reduce dead volume space within said first receivingchamber.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, further comprising a fillingmaterial introduced into said cap to reduce dead volume space withinsaid first receiving chamber.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredient insaid first receiving chamber is selected from the group consisting of apharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietarysupplement and a mineral.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredient insaid second receiving chamber is selected from the group consisting of apharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietarysupplement and a mineral.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredient insaid first receiving chamber comprises a pharmaceutical and saidingredient in said second receiving chamber comprises a pharmaceutical.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredient insaid first receiving chamber comprises a pharmaceutical and saidingredient in said second receiving chamber is selected from the groupconsisting of a biotechnical, a nutraceutical, a vitamin, a dietarysupplement and a mineral.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said physical stateof said ingredient in said first receiving chamber is selected from thegroup consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said physical stateof said ingredient in said second receiving chamber is selected from thegroup consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said time-releasecoating of said second receiving chamber is different from saidtime-release coating of said primary capsule.

In another embodiment of the present invention, there is amulti-compartment capsule, comprising a primary capsule comprising atleast one ingredient having a first physical state; a secondary capsulecomprising at least one ingredient having a second physical state; saidfirst physical state of said ingredient of said primary capsule beingdifferent from said second physical state of said ingredient of saidsecondary capsule; and said primary capsule comprising an internalperiphery sufficient for receiving said ingredient and said secondarycapsule therein.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said primary capsulefurther comprises a base and a corresponding cap, wherein said cap isconfigured to provide a sealing relationship when engaging said base.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said primary capsulecomprises no dead volume space.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredient insaid primary capsule is selected from the group consisting of apharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietarysupplement and a mineral.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredient insaid secondary capsule is selected from the group consisting of apharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietarysupplement and a mineral.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredient insaid first receiving chamber comprises a pharmaceutical and saidingredient in said second receiving chamber comprises a pharmaceutical.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredientintroduced in said primary capsule comprises a moisture content in therange of about 0% to 6% by weight.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredientintroduced in said secondary capsule comprises a moisture content in therange of about 0% to 6% by weight.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said primary andsecondary capsules contain at least one pharmaceutically acceptablelubricant in the range of about 0% to 10% by weight.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said lubricant isselected from the group consisting of aluminiumstearate,calciumstearate, magnesiumstearate, tinstearate, talc, sodium laurylsulfate, lecithins, mineral oils, stearic acid, silicones and mixturesthereof.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said primary andsecondary capsules have different colors.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said primary capsuleis formed having a first color.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said secondarycapsule is formed having a second color different from said first colorof said primary capsule.

In another embodiment of the present invention, there is amulti-compartment capsule, comprising a capsule comprising alongitudinally extending body having a length; at least one dividingwall formed along said length of said extending body, said dividing wallforming a first receiving chamber and a second receiving chamber; saidfirst receiving chamber comprising at least one ingredient having afirst physical state; said second receiving chamber comprising at leastone ingredient having a second physical state; and said first physicalstate of said ingredient of said first receiving chamber being differentfrom said second physical state of said ingredient of said secondreceiving chamber.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said capsule furthercomprises a base and a corresponding cap, wherein said cap is configuredto provide a sealing relationship when engaging said base.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said base and saidcap are formed having different colors.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said sealingrelationship between said base and corresponding cap comprises no deadvolume space within said capsule.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredient insaid first receiving chamber comprises a pharmaceutical and saidingredient in said second receiving chamber comprises a pharmaceutical.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said ingredient insaid first receiving chamber comprises a pharmaceutical and saidingredient in said second receiving chamber is selected from the groupconsisting of a biotechnical, a nutraceutical, a vitamin, a dietarysupplement and a mineral.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said first physicalstate of said ingredient in said first receiving chamber is selectedfrom the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said second physicalstate of said ingredient in said second receiving chamber capsule isselected from the group consisting of a solid, a liquid, a gas and adispersion.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said capsulecomprises a time-release coating.

In another embodiment of the present invention, there is amulti-compartment capsule as defined in above, wherein said capsule isformed of a material selected from the group consisting of gelatin,starch, casein, chitosan, soya bean protein, safflower protein,alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin,succinated gelatin, cellulosephtalate-acetate, polyvinylacetate,hydroxypropyl methyl cellulose, oleoresin, polymerisates of acrylic ormethacrylic esters, polyvinylacetate-phtalate and mixtures thereof.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said capsule furthercomprises a soft elastic capsule formed of a material selected from thegroup consisting of glycerin and sorbitol.

In another embodiment of the present invention, there is amulti-compartment capsule as defined above, wherein said lubricant isselected from the group consisting of aluminiumstearate,calciumstearate, magnesiumstearate, tinstearate, talc, sodium laurylsulfate, lecithins, mineral oils, stearic acid, silicones and mixturesthereof.

In another embodiment of the present invention, there is anencapsulation process for forming a multi-compartment capsule, saidprocess comprising the steps of providing a primary capsule having abase and a cap; providing a secondary capsule having a base and a cap;introducing at least one ingredient having a first physical state intosaid secondary capsule; positioning said cap of said secondary capsulein sealing relationship with said base; introducing at least oneingredient having a second physical state into said primary capsule,wherein said first physical state of said ingredient of said secondarycapsule is different from said second physical state of said ingredientof said primary capsule; introducing said secondary capsule into saidbase of said primary capsule; and positioning said cap of said primarycapsule in sealing relationship with said base.

In another embodiment of the present invention, there is anencapsulation process as defined above, further comprising the step ofreducing dead volume space within said primary capsule.

In another embodiment of the present invention, there is anencapsulation process as defined above, further comprising the step ofintroducing a filling material into said cap of said primary capsule toreduce dead volume space.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said cap of said primarycapsule comprises a configuration sufficient for reducing dead volumespace within the primary capsule.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredientintroduced into said primary capsule is selected from the groupconsisting of a pharmaceutical, a biotechnical, a nutraceutical, avitamin, a dietary supplement and a mineral.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said physical state ofsaid ingredient in said primary capsule is selected from the groupconsisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredient in saidsecondary capsule is selected from the group consisting of apharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietarysupplement and a mineral.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said physical state ofsaid ingredient in said secondary capsule is selected from the groupconsisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredient in saidprimary capsule comprises a pharmaceutical and said ingredient in saidsecondary capsule is selected from the group consisting of apharmaceutical.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredient in saidprimary capsule comprises a pharmaceutical and said ingredient in saidsecondary capsule is selected from the group consisting of abiotechnical, a nutraceutical, a vitamin, a dietary supplement and amineral.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredientintroduced into said primary capsule is the same as said ingredientintroduced into said secondary capsule.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said time-releasecoating of said secondary capsule is different from said time-releasecoating of said primary capsule.

In another embodiment of the present invention, there is anencapsulation process as defined above, further comprising the steps ofproviding a tertiary capsule having a base and a cap; introducing atleast one ingredient having a third physical state into said tertiarycapsule; positioning said cap of said secondary capsule in sealingrelationship with said base; and introducing said tertiary capsule intosaid base of said secondary capsule.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredient in saidtertiary capsule is selected from the group consisting of apharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietarysupplement and a mineral.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredient in saidtertiary capsule comprises a physical state selected from the groupconsisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said tertiary capsulecomprises a time-release coating.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said lubricant isselected from the group consisting of aluminiumstearate,calciumstearate, magnesiumstearate, tinstearate, talc, sodium laurylsulfate, lecithins, mineral oils, stearic acid, silicones andcombinations thereof.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said primary andsecondary capsules are formed having different colors.

In another embodiment of the present invention, there is anencapsulation process for forming a multi-compartment capsule, saidprocess comprising the steps of providing a capsule comprising a cap, abase configured having a longitudinally extending body including alength and at least one dividing wall formed along said length of saidextending body, said dividing wall adapted to form a first receivingchamber and a second receiving chamber; introducing at least oneingredient having a first physical state into said second receivingchamber; introducing at least one ingredient having a second physicalstate into said first receiving chamber, wherein said first physicalstate of said ingredient of said second receiving chamber beingdifferent from said second physical state of said ingredient of saidfirst receiving chamber; and positioning said cap in sealingrelationship with said base.

In another embodiment of the present invention, there is anencapsulation process as defined above, further comprising the step ofreducing dead volume space within said primary capsule.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said filling material isselected from the group consisting of gelatin, starch, casein, chitosan,soya bean protein, safflower protein, alginates, gellan gum,carrageenan, xanthan gum, phtalated gelatin, succinated gelatin,cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methylcellulose, polyvinylacetate-phtalate, polymerisates of acrylic ormethacrylic esters and combinations thereof.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said cap comprises aconfiguration sufficient for reducing dead volume space within saidcapsule.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredient in saidfirst receiving chamber is selected from the group consisting of apharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietarysupplement and a mineral.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said physical state ofsaid ingredient in said receiving chamber is selected from the groupconsisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredient in saidsecond receiving chamber is selected from the group consisting of apharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietarysupplement and a mineral.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said physical state ofsaid ingredient in said second receiving chamber is selected from thegroup consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredient in saidfirst receiving chamber comprises a pharmaceutical and said ingredientin said second receiving chamber is selected from the group consistingof a pharmaceutical.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said time-releasecoating, of said second receiving chamber is different from saidtime-release coating of said first receiving chamber.

In another embodiment of the present invention, there is anencapsulation process as defined above, further comprising the steps ofpositioning a second dividing wall along said length of said extendingbody of said base, said second dividing wall adapted to form a thirdreceiving chamber; and introducing at least one ingredient having aphysical state into said third receiving chamber.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said ingredientintroduced into said third receiving chamber is selected from the groupconsisting of a pharmaceutical, a biotechnical, a nutraceutical, avitamin, a dietary supplement and a mineral.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said physical state ofsaid ingredient introduced into said third receiving chamber is selectedfrom the group consisting of a solid, a liquid, a gas and a dispersion.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said second dividingwall comprises a time-release coating.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said capsule furthercomprises a soft elastic capsule formed of a material selected from thegroup consisting of glycerin and sorbitol.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said lubricant isselected from the group consisting of aluminiumstearate,calciumstearate, magnesiumstearate, tinstearate, talc, sodium laurylsulfate, lecithins, mineral oils, stearic acid, silicones andcombinations thereof.

In another embodiment of the present invention, there is anencapsulation process as defined above, wherein said base and said capof said capsule are formed having different colors.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects and features of the present inventionwill become more fully apparent from the following description andappended claims, taken in conjunction with the accompanying drawings.Understanding that these drawings depict only typical embodiments of theinvention and are, therefore, not to be considered limiting of itsscope, the invention will be described with additional specificity anddetail through use of the accompanying drawings in which:

FIG. 1 is a flow diagram illustrating one presently preferred embodimentof a process of the present invention comprising the steps ofintroducing at least one active ingredient or medicament having a solidphysical state into a secondary capsule and introducing the secondarycapsule into a primary capsule further including at least one activeingredient or medicament having a liquid physical state;

FIG. 2 is a cross-sectional view illustrating another presentlypreferred embodiment of a multi-compartment capsule of the presentinvention wherein a primary capsule houses a secondary capsule and asecondary capsule houses a tertiary capsule, wherein each of thecapsules include one or more active ingredients or medicaments and theactive ingredient(s) introduced into at least two of the capsulescomprise different physical states;

FIG. 3 is a perspective view illustrating yet another presentlypreferred embodiment of a multi-compartment capsule comprising a base, acap and a dividing wall positioned between the base and the cap, whereinthe dividing wall facilitates the formation of at least two, independentreceiving chambers for receiving one or more active ingredients ormedicaments having different physical states;

FIG. 4 is a cross-sectional view of the multi-compartment capsule shownin FIG. 3 wherein the base, the dividing wall defining the two receivingchambers and the cap are assembled to form a capsule of the presentinvention and wherein one or more active ingredients or medicamentshaving different physical states are introduced into the receivingchambers;

FIG. 5 is a perspective view illustrating an alternate presentlypreferred embodiment of a multi-compartment capsule of the presentinvention having a primary capsule comprising a capsular base configuredwith a longitudinally extending body, a corresponding cap and a seriesof dividing walls disposed in spaced apart relationship along the lengthof the longitudinally extending body of the base, wherein the dividingwalls define a plurality of independent receiving chambers having aninternal periphery sufficient for introducing one or more activeingredients or medicaments having different physical states therein andfor introducing a secondary capsule, having one or more activeingredients contained therein, within at least one of said receivingchambers;

FIG. 6 is a cross-sectional view of the multi-compartment capsule shownin FIG. 5 wherein the base and the cap are assembled to form a singledosage capsule having a series of dividing walls that define a pluralityof chambers for receiving one or more active ingredients or medicaments,wherein the active ingredient(s) in at least two of the receivingchambers comprise different physical states;

FIG. 7 is a perspective view illustrating yet another presentlypreferred embodiment of a multi-compartment capsule of the presentinvention having a primary capsule comprising a capsular base configuredwith a longitudinally extending body, a corresponding cap and a seriesof dividing walls disposed in spaced apart relationship, both verticallyand horizontally, along the length of the longitudinally extending bodyof the base, wherein the dividing walls define a plurality ofindependent receiving chambers having an internal periphery sufficientfor introducing one or more active ingredients or medicaments havingdifferent physical states therein;

FIG. 8 is a perspective view illustrating an alternate preferredembodiment of the multi-compartment capsule shown in FIG. 7, wherein themulti-compartment capsule includes a primary capsule comprising acapsular base configured with a longitudinally extending body, acorresponding cap and a series of dividing walls disposed in spacedapart relationship, both vertically and horizontally, along the lengthof the longitudinally extending body of the base, wherein the dividingwalls define a plurality of independent receiving chambers having aninternal periphery sufficient for introducing one or more activeingredients or medicaments having different physical states therein andfor introducing a secondary capsule, having one or more activeingredients contained therein, within at least one of said receivingchambers;

FIG. 9 is a perspective view illustrating yet another presentlypreferred embodiment of a multi-compartment capsule of the presentinvention wherein the multi-compartment capsule shown in FIG. 7 isintroduced within the internal periphery of a receiving chamber of aprimary capsule having one or more active ingredients also containedtherein;

FIG. 10 is a cross-sectional view illustrating a presently preferredembodiment of a multi-compartment capsule of the present inventionincluding a secondary capsule having one or more active ingredients ormedicaments selectively introduced into the internal periphery of aprimary capsule having one or more active ingredients or medicaments,wherein the active ingredient(s) introduced into the primary capsulecomprises a physical state (e.g., solid, liquid, gas or dispersion)which differs from the physical state of the active ingredient(s)introduced into the internal periphery of the secondary capsule, theprimary capsule further comprising a cap having a generally U-shapedconfiguration adapted to provide a sealing relationship when engagingthe corresponding base, thereby reducing dead space volume in theinternal periphery of the receiving chamber of the base;

FIG. 11 is a perspective view illustrating yet another presentlypreferred embodiment of a multi-compartment capsule of the presentinvention including a secondary capsule having one or more activeingredients or medicaments and having a size and shape sufficient forbeing selectively introduced into the internal periphery of a primarycapsule having one or more active ingredients or medicaments, whereinthe active ingredient(s) introduced into the primary capsule comprises aphysical state (e.g., solid, liquid, gas or dispersion) which differsfrom the physical state of the active ingredient(s) introduced into theinternal periphery of the secondary capsule, the primary capsule furthercomprising a filling material introduced into the internal periphery ofthe cap having a general conical configuration and adapted to provide asealing relationship when engaging the corresponding base, therebyreducing dead space volume in the internal periphery of the receivingchamber of the base;

FIG. 12 is a cross-sectional view of the multi-compartment capsule shownin FIG. 11 wherein a sufficient amount of filling material is introducedinto the internal periphery of the cap, thereby functioning to eliminateor significantly reduce the dead space volume in the receiving chamberof the primary capsule; and

FIG. 13 is a cross-sectional view illustrating an alternate presentlypreferred embodiment of a multi-compartment capsule of the presentinvention comprising a tertiary capsule having one or more activeingredients or medicaments and having a size a shape sufficient forbeing introduced into at least a portion of the internal periphery ofthe receiving chamber of a secondary capsule having one or more activeingredients or medicaments also introduced therein, the size and shapeof the secondary capsule sufficient for being selectively introducedinto the internal periphery of a primary capsule having one or moreactive ingredients or medicaments, wherein the active ingredient(s)introduced into the primary capsule comprises, a physical state (e.g.,solid, liquid, gas or dispersion) which differs from the physical stateof the active ingredient(s) introduced into the receiving chambers ofthe secondary and tertiary capsules, the primary capsule furthercomprising a filling material introduced into the internal periphery ofthe cap having a general conical configuration and adapted to provide asealing relationship when engaging the corresponding base, therebyreducing dead space volume in the internal periphery of the receivingchamber of the base of the primary capsule.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

It will be readily understood that the components of the presentinvention, as generally described and illustrated in the Figures herein,could be arranged and designed in a wide variety of differentconfigurations and process steps. Those of ordinary skill in the artwill, of course, appreciate that various modifications to the detailsherein may easily be made without departing from the essentialcharacteristics of the invention, as described. Thus, the following moredetailed description of the embodiments of apparatus and methods of thepresent invention, as represented in FIGS. 1 through 13, is not intendedto limit the scope of the invention, as claimed, but it is merelyrepresentative of the presently preferred embodiments of the invention.

The presently preferred embodiments of the invention will be bestunderstood by reference to the drawings, wherein like parts aredesignated by like numerals throughout.

One presently preferred embodiment of the present invention, designatedgenerally at 10, is best illustrated in FIG. 1. As shown, amulti-compartment capsule 10 is illustrated comprising a primary capsule11 and a secondary capsule 20 selectively introduced within at least aportion of an internal periphery of the primary capsule. The secondarycapsule 20 includes a base 24, a corresponding cap 22 and a receivingchamber 28 formed between the base and cap. The receiving chamber 28 isconfigured having an internal periphery sufficient for receiving atleast one active ingredient or medicament (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof) therein. In similar structural design, the primarycapsule 11 may be formed having a base 14, a corresponding cap 12 and areceiving chamber 18 formed between the base and cap. The receivingchamber 18 of the primary capsule 11 is preferably formed having aninternal periphery sufficient for receiving the secondary capsule 20,together with at least one active ingredient or medicament (e.g.,pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof) therein.

Still referring to FIG. 1, one presently preferred embodiment of anencapsulation process for forming a multi-compartment capsule 10 iscomprising the steps of: (1) providing a primary capsule 11 having abase 14, a corresponding cap 12 and a receiving chamber 18; (2)providing a secondary capsule 20 having a base 24, a corresponding cap22 and a receiving chamber 28; (3) introducing at least one ingredientor medicament (e.g., pharmaceutical, biotechnical, nutraceutical,vitamin, dietary supplement, mineral or combination thereof) having afirst physical state (e.g., solid, liquid, gas or dispersion) into atleast a portion of the receiving chamber 28 of the secondary capsule 20and selectively positioning the cap 22 in sealing relationship with thebase 24; (4) introducing at least one ingredient or medicament (e.g.,pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof) having a second physicalstate (e.g., solid, liquid, gas or dispersion) into at least a portionof the receiving chamber 18 of the primary capsule 11, wherein the firstphysical state of the ingredient(s) in the secondary capsule isdifferent from the second physical state of the ingredient(s) in theprimary capsule; and (5) introducing the secondary capsule 20 into atleast a portion of the receiving chamber 18 of the primary capsule 11and selectively positioning the cap 12 in sealing relationship with thebase 14 to form a single dosage multi-compartment capsule.

As shown, a solid is selectively introduced within at least a portion ofthe internal periphery of the receiving chamber 28 of the secondarycapsule 20 and a liquid is selectively introduced within at least aportion of the internal periphery of the receiving chamber 18 of theprimary capsule 11. Although the ingredient(s) introduced into thereceiving chamber 18 of the primary capsule 11 may be the same ordifferent from the ingredient(s) introduced into the receiving chamber28 of the secondary capsule, the active ingredient(s) in the primarycapsule 11 have a physical state (i.e., solid, liquid, gas ordispersion) that varies from the physical state of the activeingredient(s) in the secondary capsule 20. Accordingly, those skilled inthe art will readily recognize other possible modifications andadaptations relative to the contemplated variations in physical statesof the active ingredient(s) selectively positionable within thereceiving chambers 18, 28 of the primary and secondary capsules,respectively, which are consistent with the spirit and scope of thepresent invention. It is intended, therefore, that the figures andexamples provided herein be viewed as exemplary of the principles of thepresent invention, and not as restrictive to a particular structure ormethod for implementing those principles.

Referring now to FIG. 2, an alternate presently preferred embodiment ofa multi-compartment capsule 110 is shown comprising a primary capsule111, a secondary capsule 120 and a tertiary capsule 130. The tertiarycapsule 130 includes a base 134, a corresponding cap 132 and a receivingchamber 138 formed between the base and cap. The receiving chamber 138is preferably formed having an internal periphery sufficient forreceiving at least one active ingredient or medicament (e.g.,pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof). Structurally, the tertiarycapsule 130 is configured having a size sufficient for being selectivelyintroduced within at least a portion of an internal periphery of areceiving chamber 128 defined between a base 124 and a corresponding cap122 of the secondary capsule 120. One or more active ingredients ormedicaments (e.g., pharmaceutical, biotechnical, nutraceutical, vitamin,dietary supplement, mineral or combination thereof) may be introducedinto at least a portion of the receiving chamber 128 of the secondarycapsule 120, together with the introduction of the tertiary capsule 130comprising its active ingredient(s). The secondary capsule 120 havingits active ingredient(s) and housing the tertiary capsule 130 with itsactive ingredient(s) may then be selectively introduced within at leasta portion of an internal periphery of a receiving chamber 118 of theprimary capsule 111 defined between a base 114 and a corresponding cap112. Preferably, the receiving chamber 118 of the primary capsule 111may also include one or more active ingredients or medicaments (e.g.,pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof) introduced therein.

Still referring to FIG. 2, another presently preferred embodiment of anencapsulation process for forming a multicompartment capsule 110 maycomprise the steps of: (1) providing a primary capsule 111 having a base114, a corresponding cap 112 and a receiving chamber 118 defined betweenthe base and cap; (2) providing a secondary capsule 120 having a base124, a corresponding cap 122 and a receiving chamber 128 defined betweenthe base and cap; (3) providing a tertiary capsule 130 having a base134, a corresponding cap 132 and a receiving chamber 138 defined betweenthe base and cap; (4) introducing at least one ingredient (e.g.,pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof) having a first physicalstate (e.g., solid, liquid, gas or dispersion) into at least a portionof the receiving chamber 138 of the tertiary capsule 130 and selectivelypositioning the cap 132 in sealing relationship with the base 134; (5)introducing at least one ingredient (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) having a second physical state (e.g., solid, liquid, gas ordispersion) into at least a portion of the receiving chamber 128 of thesecondary capsule 120, wherein the first physical state of theingredient(s) in the tertiary capsule 130 are the same as the secondphysical state of the ingredient(s) in the secondary capsule 120; (6)introducing the tertiary capsule 130 into at least a portion of thereceiving chamber 218 of the secondary capsule 120 and selectivelypositioning the cap 122 in sealing relationship with the base 124; (7)introducing at least one ingredient (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) having a third physical state (e.g., solid, liquid, gas ordispersion) into at least a portion of the receiving chamber 118 of theprimary capsule 111, wherein the third physical state of theingredient(s) in the primary capsule are different from the first andsecond physical states of the ingredient(s) in the tertiary capsule 130and the secondary capsule 120, respectively; and (8) introducing thesecondary capsule 120 into at least a portion of the receiving chamber118 of the primary capsule 111 and selectively positioning the cap 112in sealing relationship with the base 114 to form a single dosagemulti-compartment capsule.

In the presently preferred embodiment illustrated in FIG. 2, a liquidmay be selectively introduced into at least a portion of the internalperiphery of the receiving chamber 118 of the primary capsule 111, asolid may be selectively introduced into at least a portion of theinternal periphery of the receiving chamber 128 of the secondary capsule120 and a solid may be selectively introduced into at least a portion ofthe receiving chamber 138 of the tertiary capsule 130. Although theingredient(s) selectively introduced into the receiving chambers 118,128, 138 of the primary, secondary and tertiary capsules 111, 120, 130,respectively, may be the same or different, the active ingredient(s) inat least two of the receiving chambers comprise at least two differentphysical states (e.g., solid, liquid, gas or dispersion). It is furthercontemplated herein as an alternate embodiment that the activeingredient(s) introduced in the receiving chamber 118 of the primarycapsule 111 comprises a physical state (e.g., solid, liquid, gas ordispersion) different from the physical state of the activeingredient(s) contained within the receiving chamber 128 of thesecondary capsule 120 which is different from the physical state of theactive ingredient(s) contained within the receiving chamber 138 of thetertiary capsule 130. Those skilled in the art will readily recognizeother possible modifications and adaptations relative to contemplatedvariations in physical states of the active ingredient(s) selectivelyintroduced within the receiving chambers 118, 128, 138 of the primary,secondary and tertiary capsules, respectively, which are consistent withthe spirit and scope of the present invention. It is intended,therefore, that the figures and examples provided herein be viewed asexemplary of the principles of the present invention, and not asrestrictive to a particular structure or method for implementing thoseprinciples.

Referring now to FIGS. 3 and 4, another presently preferred embodimentof a multi-compartment capsule 210 is shown comprising a base 214, acorresponding cap 212 and a dividing wall 216 positionable between thebase and the cap. Structurally, the size, shape and positioning of thedividing wall 216 relative to the base 214 and corresponding cap 212facilitates the formation of at least two, independent and separatereceiving chambers 218 a, 218 b, each having an internal peripherysufficient for receiving one or more active ingredients or medicaments(e.g., pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof) therein. As best shown inFIG. 4, the dividing wall 216 seats within the internal periphery ofboth the base 214 and the corresponding cap 212. After introducing oneor more active ingredients or medicaments into receiving chamber 218 band disposing the dividing wall 216 relative thereto, one or more activeingredients or medicaments (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) may be introduced into receiving chamber 218 a and the cap maybe selectively positioned in sealing relationship with the base 214 toform one presently preferred embodiment of the single, dosagemulti-compartment capsule 210. Moreover, the dividing wall 216 mayfunctionally assist in forming a sealing relationship between the base214 and corresponding cap 212 of the multi-compartment capsule 210, ifdesired.

In one presently preferred embodiment of the multi-compartment capsule211 of the present invention, a solid may be selectively introduced intoat least a portion of the internal periphery of the receiving chamber218 a and a liquid may be selectively introduced into at least a portionof the internal periphery of the receiving chamber 21 b. Although theingredient(s) introduced into the receiving chamber 218 a may be thesame or different from the ingredient(s) introduced into the receivingchamber 218, the active ingredient(s) in the first receiving chamber 218a preferably comprise a physical state (e.g., solid, liquid, gas ordispersion) that is different from the physical state of the activeingredient(s) in the second receiving chamber 218 b. Those skilled inthe art will readily recognize other possible modifications andadaptations relative to the contemplated variations in physical states(e.g., solid, liquid, gas and dispersion) of the active ingredient(s)selectively positionable within the receiving chambers 218 a, 218 bwhich are consistent with the spirit and scope of the present invention.It is intended, therefore, that the figures and examples provided hereinbe viewed as exemplary of the principles of the present invention, andnot as restrictive to a particular structure or method for implementingthose principles.

Referring now to FIGS. 5 and 6, another presently preferred embodimentof a multi-compartment capsule, designated as 310, is shown including aprimary capsule 311 comprising a capsular base 314 configured having anelongated or longitudinally extending body, a corresponding cap 312 anda plurality of dividing walls 316 selectively disposed along the lengthof the longitudinally extending body of the base. Preferably, thestructural size, shape and positioning of the dividing walls 316 a, 316b, 316 c along the length of the elongated body of the base 314facilitate the formation of a plurality of independent receivingchambers 318 a, 318 b, 318 c, 318 d. Each receiving chamber 318 a, 318b, 318 c, 318 d of the primary capsule 311 having an internal peripherysufficient for receiving one or more active ingredients or medicaments(e.g., pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof) therein.

As best shown in FIG. 6, the dividing walls 316 a, 316 b, 316 arepreferably seated within the internal periphery of the base 314 of theprimary capsule 311 and in a spaced apart relationship along the lengthof the longitudinally extending body and form four independent receivingchambers 318 a, 318 b, 318 c, 318 d. In one presently preferredembodiment of the multi-compartment capsule 310 of the presentinvention, each of the receiving chambers 318 a, 318 b, 318 c comprisesat least one active ingredient or medicament having a physical state(e.g., solid, liquid, gas or dispersion) different from the physicalstate of the ingredient(s) in the other receiving chambers.

As illustrated by way of example, and not by way of restriction, a solidmay be selectively introduced into at least a portion of the internalperiphery of the receiving chamber 318 a, a dispersion may beselectively introduced into at least a portion of the internal peripheryof the receiving chamber 318 b, a liquid may be selectively introducedinto at least a portion of the internal periphery of the receivingchamber 318 c and a secondary capsule 320 may be selectively introducedinto at least a portion of the internal periphery of the receivingchamber 318 d. As contemplated herein, receiving chamber 318 d may befurther configured having an internal periphery sufficient for receivinga secondary capsule 320, together with at least one active ingredient ormedicament therein.

One presently preferred embodiment of an encapsulation process, asdefined by the structural configuration of the multi-compartment capsule310 illustrated in FIGS. 5 and 6, may comprise the steps of: (1)introducing a secondary capsule 320 (e.g., tablet) and one or moreactive ingredients or medicaments into receiving chamber 318 d; (2)selectively positioning dividing wall 316 c along the length of theelongated body of the base 314; (3) introducing one or more activeingredients or medicaments (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) into receiving chamber 318 c; (4) selectively positioningdividing wall 316 b along the length of the elongated body of the base314 in a spaced apart relationship to dividing wall 316 c; (5)introducing one or more active ingredients or medicaments (e.g.,pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof) into receiving chamber 318b; (6) selectively positioning dividing wall 316 a along the length ofthe elongated body of the base 314 in a spaced apart relationship todividing wall 316 b; and (7) selectively positioning the cap 312 insealing relationship with the base 314 to form a presently preferredembodiment of a single, dosage multi-compartment capsule 310. Thedividing wall 316 a may also function in the formation of the sealingrelationship between the base 314 and the corresponding cap 312, ifdesired.

Although the ingredient(s) introduced into one of the receiving chambers318 may be the same ingredient or may be different from theingredient(s) introduced into the other receiving chambers, the activeingredient(s) in at least two of the receiving chambers 318 preferablycomprise a physical state (e.g., solid, liquid, gas or dispersion) thatis different from the physical state of the active ingredient(s) in oneor more of the remaining receiving chambers. Those skilled in the artwill readily recognize other possible modifications and adaptationsrelative to the contemplated variations in physical states (e.g., solid,liquid, gas and dispersion) of the active ingredient(s) selectivelyintroduced within the receiving chambers 318 which are consistent withthe spirit and scope of the present invention. It is intended,therefore, that the figures and examples provided herein be viewed asexemplary of the principles of the present invention, and not asrestrictive to a particular structure or method for implementing thoseprinciples.

Another presently preferred embodiment of a multi-compartment capsule ofthe present invention, generally designated as 410 in FIG. 7, is showncomprising a capsular base 414 preferably configured having an elongatedor longitudinally extending body, a corresponding cap 412 and aplurality of dividing walls 416 selectively disposed along the length ofthe longitudinally extending body of the base, both horizontally andvertically. In structural design, the size, shape and positioning of thedividing walls 416 a, 416 b, 416 c, 416 d, 416 e along the length of thelongitudinally extending body of the base 414 facilitate the formationof a plurality of independent receiving chambers 418.

In one presently preferred embodiment, the dividing walls 416 a, 416 b,416 e, 416 d, 416 e are preferably disposed or seated in a spaced apartrelationship within the internal periphery of the base 414 of theprimary capsule 411 along the length of the longitudinally extendingbody, whereby forming five (5) independent receiving chambers 418 a, 418b, 418 c, 418 d, 418 e. Each receiving chamber 418 a, 418 b, 418 c, 418d, 418 e of the primary capsule 411 are preferably configured having aninternal periphery dimensionally sufficient for receiving one or moreactive ingredients or medicaments (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) therein.

Still referring to FIG. 7, one presently preferred embodiment of anencapsulation process, as defined by the structural configuration of themulti-compartment capsule 410, may comprise the steps of: (1)introducing one or more active ingredients or medicaments into receivingchamber 418 e defined by dividing walls 416 d, 416 e which arevertically disposed along the length of the elongated body of the base414; (2) introducing one or more active ingredients or medicaments intoreceiving chamber 418 d defined by dividing walls 416 c, 416 d which arevertically disposed along the length of the elongated body of the base414; (3) introducing one or more active ingredients or medicaments intoreceiving chamber 418 c defined by dividing walls 416 b, 416 c which arevertically disposed along the length of the elongated body of the base414; (4) introducing one or more active ingredients or medicaments intoreceiving chamber 418 b defined by dividing walls 416 b, 416 e which arevertically disposed along the length of the elongated body of the base414; (5) disposing dividing wall 416 a along the length of the elongatedbody of the base 414 perpendicular to the disposition of dividing walls416 b, 416 c, 416 d, 416 e and introducing one or more activeingredients or medicaments into receiving chamber 418 a; and (6)selectively positioning the cap 412 in scaling relationship with thebase 414 to form one presently preferred embodiment of a single, dosagemulti-compartment capsule 410. As appreciated, the dividing wall 416 amay also function in the formation of the sealing relationship betweenthe base 414 and the corresponding cap 412, if structurally desired.

As illustrated by way of example, and not by way of restriction, a solidmay be selectively introduced into at least a portion of the internalperiphery of the receiving chamber 418 a, a dispersion may beselectively introduced into at least a portion of the internal peripheryof the receiving chamber 418 b, a liquid may be selectively introducedinto at least a portion of the internal periphery of the receivingchamber 418 c, a solid may be selectively introduced into at least aportion of the internal periphery of the receiving chamber 418 d and aliquid may be selectively introduced into at least a portion of theinternal periphery of the receiving chamber 418 e.

Although the ingredient(s) introduced into one of the receiving chambers418 may be the same ingredient or may be different from theingredient(s) introduced into the other receiving chambers, the activeingredient(s) in at least two of the receiving chambers 418 preferablycomprise a physical state (e.g., solid, liquid, gas or dispersion) thatis different from the physical state of the active ingredient(s) in oneor more of the remaining receiving chambers. Those skilled in the artwill readily recognize other possible modifications and adaptationsrelative to the contemplated variations in physical states (e.g., solid,liquid, gas and dispersion) of the active ingredient(s) selectivelyintroduced within the receiving chambers 418 which are consistent withthe spirit and scope of the present invention. It is intended,therefore, that the figures and examples provided herein be viewed asexemplary of the principles of the present invention, and not asrestrictive to a particular structure or method for implementing thoseprinciples.

Referring now to FIG. 8, an alternate presently preferred embodiment ofa multi-compartment capsule 510 includes a capsular base 514 preferablyconfigured having an elongated or longitudinally extending body, acorresponding cap 512 and a plurality of dividing walls 516 selectivelydisposed along the length of the longitudinally extending body of thebase, both horizontally and vertically. In structural design, the size,shape and positioning of the dividing walls 516 a, 516 b, 516 c, 516 dalong the length of the longitudinally extending body of the base 514facilitate the formation of a plurality of independent receivingchambers 518.

In one presently preferred embodiment, the dividing walls 516 a, 516 b,516G, 516 d, 516 e are preferably disposed or seated in a spaced apartrelationship within the internal periphery of the base 514 of theprimary capsule 511 along the length of the longitudinally extendingbody, whereby forming five (5) independent receiving chambers 518 a, 518b, 518 c, 518 d, 518 e. Each of the receiving chamber 518 a, 518 b, 518c, 518 d, 518 e of the primary capsule 411 are preferably configuredhaving an internal periphery dimensionally sufficient for receiving oneor more active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof) therein. Moreover, receiving chamber 518 d isformed having an internal periphery sufficient for receiving a secondarycapsule 520. The secondary capsule 520 being configured with a base 524,corresponding cap 522 and a dividing wall 526 defining a first receivingchamber 528 a and a second receiving chamber 528 b. The first receivingchamber 528 a is preferably configured having an internal peripherysufficient for receiving one or more active ingredients or medicaments(e.g., pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof) having a first physicalstate (e.g., solid, liquid, gas or dispersion) therein. Similarly, thesecond receiving chamber 528 b is configured having an internalperiphery sufficient for receiving one or more active ingredients ormedicaments (e.g., pharmaceutical, biotechnical, nutraceutical, vitamin,dietary supplement, mineral or combination thereof) having a secondphysical state (e.g., solid, liquid, gas or dispersion), wherein thephysical state of the ingredient(s) in the second receiving chambervaries from the physical state of the ingredient(s) in the firstreceiving chamber. As contemplated and disclosed hereinabove, after theingredients are introduced into the respective receiving chambers 528 a,528 b, the cap 522 may be positioned in sealing relationship with thebase 524 of the secondary capsule 520.

Still referring to FIG. 8, as illustrated by way of example, and not byway of restriction, a solid may be selectively introduced into at leasta portion of the internal periphery of the receiving chamber 528 a and aliquid may be selectively introduced into at least a portion of theinternal periphery of the receiving chamber 528 b. Although theingredient(s) introduced into one of the receiving chamber 528 a may bethe same ingredient or maybe different from the ingredient(s) introducedinto receiving chamber 528 b, the active ingredient(s) in the firstreceiving chamber 528 a comprise a physical state (e.g., solid, liquid,gas or dispersion) that is different from the physical state of theactive ingredient(s) in receiving chambers 528 b. Those skilled in theart will readily recognize other possible modifications and adaptationsrelative to the contemplated variations in physical states (e.g., solid,liquid, gas and dispersion) of the active ingredient(s) selectivelyintroduced within the receiving chambers 528 which are consistent withthe spirit and scope of the present invention. It is intended,therefore, that the figures and examples provided herein be viewed asexemplary of the principles of the present invention, and not asrestrictive to a particular structure or method for implementing thoseprinciples.

One presently preferred embodiment of an encapsulation process, asdefined by the structural configuration of the multi-compartment capsule510, may comprise the steps of (1) introducing one or more activeingredients or medicaments (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) into receiving chamber 518 e defined by dividing walls 516 d,516 e which are disposed vertically along the length of the elongatedbody of the base 514; (2) introducing a secondary capsule 520 intoreceiving chamber 518 d defined by dividing walls 516 c, 516 d which aredisposed vertically along the length of the elongated body of the base514; (3) introducing one or more active ingredients or medicaments(e.g., pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof) into receiving chamber 518 cdefined by dividing walls 516 b, 516 c which are disposed verticallyalong the length of the elongated body of the base 514; (4) introducingone or more active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof) into receiving chamber 518 b defined by dividingwalls 516 b, 516 e which are disposed vertically along the length of theelongated body of the base 514; (5) disposing dividing wall 516 a alongthe length of the elongated body of the base 514 perpendicular to thedisposition of dividing walls 516 b, 516 c, 516 d, 516 e and introducingone or more active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof) into receiving chamber 518 a; and (6) selectivelypositioning the cap 512 in sealing relationship with the base 514 toform one presently preferred embodiment of a single, dosagemulti-compartment capsule 510. As appreciated, the dividing wall 516 amay also function in the formation of the sealing relationship betweenthe base 514 and the corresponding cap 512, if structurally desired.

As illustrated by way of example, and not by way of limitation, a solidmay be selectively introduced into at least a portion of the internalperiphery of receiving chamber 518 a, a dispersion may be selectivelyintroduced into at least a portion of the internal periphery ofreceiving chamber 518 b, a liquid may be selectively introduced into atleast a portion of the internal periphery of the receiving chamber 518 cand a liquid may be selectively introduced into at least a portion ofthe internal periphery of the receiving chamber 518 e. Although theingredient(s) introduced into one of the receiving chambers 518 may bethe same ingredient or may be different from the ingredient(s)introduced into the other receiving chambers, the active ingredient(s)in at least two of the receiving chambers 518 preferably comprise aphysical state (e.g., solid, liquid, gas or dispersion) that isdifferent from the physical state of the active ingredient(s) in one ormore of the remaining receiving chambers. Those skilled in the art willreadily recognize other possible modifications and adaptations relativeto the contemplated variations in physical states (e.g., solid, liquid,gas and dispersion) of the active ingredient(s) selectively introducedwithin the receiving chambers 518 which are consistent with the spiritand scope of the present invention. It is intended, therefore, that thefigures and examples provided herein be viewed as exemplary of theprinciples of the present invention, and not as restrictive to aparticular structure or method for implementing those principles.

Referring now to FIG. 9, yet another presently preferred embodiment of amulti-compartment capsule of the present invention, generally designatedas 610, is shown comprising a primary capsule 611 and a secondarycapsule 620 selectively positionable within at least a portion of aninternal periphery of the primary capsule. The primary capsule 611having a receiving chamber 618 preferably formed having an internalperiphery sufficient for receiving the secondary capsule 620, togetherwith one or more active ingredients or medicaments (e.g.,pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof) therein. The secondarycapsule 620 comprising a capsular base 624 preferably configured havingan elongated or longitudinally extending body, a corresponding cap 622and a plurality of dividing walls 626 selectively disposed along thelength of the longitudinally extending body of the base, bothhorizontally and vertically. In structural design, the size, shape andpositioning of the dividing walls 626 a, 626 b, 626 c, 626 d along thelength of the longitudinally extending body of the base 624 facilitatethe formation of a plurality of independent receiving chambers 628.

In one presently preferred embodiment, the dividing walls 626 a, 626 b,626 c, 626 d, 426 e are preferably disposed or seated in a spaced apartrelationship within the internal periphery of the base 624 of thesecondary capsule 620 along the length of the longitudinally extendingbody, whereby forming five (5) independent receiving chambers 628 a, 628b, 628 c, 628 d, 628 e. Each receiving chamber 628 a, 628 b, 628 c, 628d, 628 e of the secondary capsule 620 are preferably configured havingan internal periphery dimensionally sufficient for receiving one or moreactive ingredients or medicaments (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) therein.

One presently preferred embodiment of an encapsulation process, asdefined by the structural configuration of the multi-compartment capsule610, may comprise the steps of: (1) introducing one or more activeingredients or medicaments (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) into receiving chamber 628 e defined by dividing walls 626 d,626 e which are vertically disposed along the length of the elongatedbody of the base 624; (2) introducing one or more active ingredients ormedicaments (e.g., pharmaceutical, biotechnical, nutraceutical, vitamin,dietary supplement, mineral or combination thereof) into receivingchamber 628 d defined by dividing walls 626 c, 626 d which arevertically disposed along the length of the elongated body of the base624; (3) introducing one or more active ingredients or medicaments(e.g., pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof) into receiving chamber 628 cdefined by dividing walls 626 b, 626 c which are vertically disposedalong the length of the elongated body of the base 624; (4) introducingone or more active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof) into receiving chamber 628 b defined by dividingwalls 626 b, 626 e which are vertically disposed along the length of theelongated body of the base 624; (5) disposing dividing wall 626 a alongthe length of the elongated body of the base 624 perpendicular to thedisposition of dividing walls 626 b, 626 c, 626 d, 626 e and introducingone or more active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof) into receiving chamber 628 a; (6) selectivelypositioning the cap 622 in sealing relationship with the base 624 of thesecondary capsule 620; (7) introducing the secondary capsule 620 and oneor more ingredients or medicaments (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) into the receiving chamber 618 of the primary capsule 611; and(8) selectively positioning the cap 612 in sealing relationship with thebase 614 of the primary capsule 611 to form one presently preferredembodiment of a single, dosage multi-compartment capsule 610.

As illustrated by way of example, and not by way of restriction, a solidmay be selectively introduced into at least a portion of the internalperiphery of the receiving chamber 628 a, a dispersion may beselectively introduced into at least a portion of the internal peripheryof the receiving chamber 628 b, a liquid may be selectively introducedinto at least a portion of the internal periphery of the receivingchamber 628 c, a solid may be selectively introduced into at least aportion of the internal periphery of the receiving chamber 628 d and aliquid may be selectively introduced into at least a portion of theinternal periphery of the receiving chamber 628 e of the secondarycapsule 620. In addition, a gas may be introduced into at least aportion of the internal periphery of the receiving chamber 618 of theprimary capsule 611.

Although the ingredient(s) introduced into one of the receiving chambers618, 628 of the primary and secondary capsules, respectively, may be thesame ingredient or may be different from the ingredient(s) introducedinto the other receiving chambers, the active ingredient(s) in at leasttwo of the receiving chambers 618, 628 preferably comprise a physicalstate (e.g., solid, liquid, gas or dispersion) that is different fromthe physical state of the active ingredient(s) in one or more of theremaining receiving chambers. Those skilled in the art will readilyrecognize other possible modifications and adaptations relative to thecontemplated variations in physical states (e.g., solid, liquid, gas anddispersion) of the active ingredient(s) selectively introduced withinthe receiving chambers 618, 628 which are consistent with the spirit andscope of the present invention. It is intended, therefore, that thefigures and examples provided herein be viewed as exemplary of theprinciples of the present invention, and not as restrictive to aparticular structure or method for implementing those principles.

Another presently preferred embodiment of a multi-compartment capsule ofthe present invention, generally designated as 710 in FIG. 10, is showncomprising a secondary capsule 720 including one or more activeingredients or medicaments (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) within at least a portion of the internal periphery of areceiving chamber 728 and having a size and shape sufficient for beingselectively introduced within at least a portion of the internalperiphery of a receiving chamber 718 of a primary capsule 711. Theprimary capsule 711 also includes one or more active ingredients ormedicaments (e.g., pharmaceutical, biotechnical, nutraceutical, vitamin,dietary supplement, mineral or combination thereof) introduced withinthe internal periphery of the receiving chamber 718, wherein the activeingredient(s) introduced into the primary capsule comprises a physicalstate (e.g., solid, liquid, gas or dispersion) which differs from thephysical state of the active ingredient(s) introduced into the internalperiphery of the secondary capsule. In structural design, the primarycapsule 711 further comprises a cap 712 having a generally U-shapedconfiguration adapted to provide a sealing relationship when engagingthe corresponding base 714, thereby reducing dead space volume in theinternal periphery of the receiving chamber 718 of the base. In thisregard, the configuration of the cap 712 generally eliminates orsubstantially reduces the potential dead space volume within theinternal periphery of the receiving chamber 718, thus functionallynegating the opportunity for reaction between an air bubble and theactive ingredient(s) introduced into the base 714 of the primary capsule711.

One presently preferred embodiment of an encapsulation process, asdefined by the structural configuration of the multi-compartment capsule710, may include the steps of (1) introducing one or more activeingredients or medicaments (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) into receiving chamber 728; (2) selectively positioning the cap722 in sealing relationship with the base 724 of the secondary capsule720; (3) introducing one or more active ingredients or medicaments(e.g., pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof), together with the secondarycapsule 720, into the receiving chamber 718 of the primary capsule 711;and (4) selectively positioning the cap 712 having a general U-shapedconfiguration in sealing relationship with the base 714 of the primarycapsule 711 to form a presently preferred embodiment of a single, dosagemulti-compartment capsule 710, wherein eliminating or substantiallyreducing dead space volume within the internal periphery of thereceiving chamber 718.

A solid is selectively introduced within at least a portion of theinternal periphery of the receiving chamber 728 of the secondary capsule720 and a liquid is selectively introduced within at least a portion ofthe internal periphery of the receiving chamber 718 of the primarycapsule 711. Although the ingredient(s) introduced into the receivingchamber 718 of the primary capsule 711 may be the same or different fromthe ingredient(s) introduced into the receiving chamber 728 of thesecondary capsule 720, the active ingredient(s) in the primary capsulehave a physical state (i.e., solid, liquid, gas or dispersion) thatvarious from the physical state of the active ingredient(s) in thesecondary capsule. Accordingly, those skilled in the art will readilyrecognize other possible modifications and adaptations relative to thecontemplated variations in physical states of the active ingredient(s)selectively introduced within the receiving chambers 718, 728 of theprimary and secondary capsules 711, 720, respectively, which areconsistent with the spirit and scope of the present invention. It isintended, therefore, that the figures and examples provided herein beviewed as exemplary of the principles of the present invention, and notas restrictive to a particular structure or method for implementingthose principles.

Referring now to FIGS. 11 and 12, yet another presently preferredembodiment of a multi-compartment capsule 810 of the present inventionis shown comprising a secondary capsule 820 including one or more activeingredients or medicaments (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) within at least a portion of the internal periphery of areceiving chamber 828. The secondary capsule 820 being preferably formedhaving a size and shape sufficient for being selectively introducedwithin at least a portion of the internal periphery of a receivingchamber 818 of a primary capsule 811. Similarly, the primary capsule 811includes one or more active ingredients or medicaments (e.g.,pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof) introduced within theinternal periphery of the receiving chamber 818, together with thesecondary capsule 820, wherein the active ingredient(s) introduced intothe primary capsule comprises a physical state (e.g., solid, liquid, gasor dispersion) which differs from the physical state of the activeingredient(s) introduced into the internal periphery of the secondarycapsule 820.

In preferred structural design, the primary capsule 811 comprises a cap812 having a general cylindrical configuration adapted to provide asealing relationship when engaging the corresponding base 814 to form asingle dosage, multi-compartment capsule 810. An amount of fillingmaterial 840 may be introduced into the internal periphery of the cap812 to fill, either partially or completely, the inner volume of thecap, thereby reducing the dead space volume in the internal periphery ofthe receiving chamber 818 of the base. In this regard, the configurationof the addition of the filler material 840 relative to the internalperiphery of the cap 812 generally eliminates or substantially reducesthe potential dead space volume within the internal periphery of thereceiving chamber 818, thus functionally negating the potential for areaction between an air bubble and the active ingredient(s) introducedinto the base 814 of the primary capsule 811.

Preferably, the filling material 840 introduced into at least a portionof the internal periphery of the cap 812 may include a hydrophilicpolymer, such as gelatin. It will be readily appreciated by thoseskilled in the art that other filling materials may be used, such as,for example, starch, casein, chitosan, soya bean protein, safflowerprotein, alginates, gellan gum, carrageenan, xanthan gum, phtalatedgelatin, succinated gelatin, cellulosephtalate-acetate,polyvinylacetate, hydroxypropyl methyl cellulose, (HPMC), oleoresin,polyvinylacetate-phtalate, polymerisates of acrylic or methacrylicesters, and mixtures thereof, or the like, and/or combinations thereof.In other presently preferred embodiments of the present invention, thefilling material 840 may include the introduction of an inert compound,for example, nitrogen gas into at least a portion of the internalperiphery of the cap 811. Based on the principals of eliminating orreducing the volume dead space in multi-compartment capsules disclosedherein, those skilled in the art will readily recognize other possiblemodifications and combinations which are consistent with the spirit andscope of the present invention. It is intended, therefore, that theexamples provided herein be viewed as exemplary of the principles of thepresent invention, and not as restrictive to a particular structure orprocess for implementing those principles.

The filling material 840 introduced within at least a portion of theinternal periphery of the cap 812 of the primary capsule 811 isgenerally intended to promote a binding contact with at least a portionof the cap 822 of the secondary capsule 820, thereby seating at least aportion of the secondary capsule within the cap of the primary capsuleand forming a molded appearance. As appreciated, the introduction of thefilling material 840 into the cap 812 of the primary capsule 811 priorto the joining and sealing process may prevent the opportunity for areaction between an air-bubble and the active medicament(s) within thereceiving chamber 818 of the primary capsule, while preserving theoverall rounded shape of the multi-compartment capsule 910 for ease ofswallowing by a consumer.

As best illustrated in FIG. 12, one presently preferred embodiment of anencapsulation process, as defined by the structural configuration of themulti-compartment capsule 810, may include the steps of: (1) introducingone or more active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin; dietary supplement, mineral orcombination thereof) into at least a portion of the receiving chamber828; (2) selectively positioning the cap 822 in sealing relationshipwith the base 824 of the secondary capsule 820; (3) introducing one ormore active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof), together with the secondary capsule 820, into atleast a portion of the receiving chamber 818 of the primary capsule 811;(4) introducing a filling material 840 into at least a portion of theinternal periphery of the cap 812 (i.e., filling the cap); and (5)selectively positioning the cap 812 having a general conicalconfiguration in sealing relationship with the base 814 of the primarycapsule 811 to form one presently preferred embodiment of a single,dosage multi-compartment capsule 810, wherein eliminating orsubstantially reducing dead space volume within the internal peripheryof the cap 812 and the receiving chamber 818, respectively.

A solid may be selectively introduced within at least a portion of theinternal periphery of the receiving chamber 828 of the secondary capsule820 and a liquid may be selectively introduced within at least a portionof the internal periphery of the receiving chamber 818 of the primarycapsule 811. Although the ingredient(s) introduced into the receivingchamber 818 of the primary capsule 811 may be the same or different fromthe ingredient(s), introduced into the receiving chamber 828 of thesecondary capsule 820, the active ingredient(s) in the primary capsulehave a physical state (i.e., solid, liquid, gas or dispersion) thatvarious from the physical state of the active ingredient(s) in thesecondary capsule. Accordingly, those skilled in the art will readilyrecognize other possible modifications and adaptations relative to thecontemplated variations in physical states of the active ingredient(s)selectively introduced within the receiving chambers 818, 828 of theprimary and secondary capsules 811, 820, respectively, which areconsistent with the spirit and scope of the present invention. It isintended, therefore, that the figures and examples provided herein beviewed as exemplary of the principles of the present invention, and notas restrictive to a particular structure or method for implementingthose principles.

Referring now to FIG. 13, another presently preferred embodiment of amulti-compartment capsule, generally designated at 910, is showncomprising a tertiary capsule 930 including one or more activeingredients or medicaments (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) within at least a portion of the internal periphery of areceiving chamber 938 and having a size and shape sufficient for beingintroduced into the internal periphery of a receiving chamber 928 of asecondary capsule 920. The secondary capsule 920 having one or moreactive ingredients or medicaments (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) introduced within at least a portion of the internal peripheryof a receiving chamber 928, together with the tertiary capsule 930. Thesecondary capsule 920 preferably formed having a size and shapesufficient for being selectively introduced within at least a portion ofthe internal periphery of a receiving chamber 918 of a primary capsule911. Similarly, the primary capsule 911 may include one or more activeingredients or medicaments (e.g., pharmaceutical, biotechnical,nutraceutical, vitamin, dietary supplement, mineral or combinationthereof) introduced within the internal periphery of the receivingchamber 818, together with the secondary capsule 920 which houses thetertiary capsule 930. In one presently preferred embodiment, the activeingredient(s) introduced into the secondary capsule 920 comprises aphysical state (e.g., solid, liquid, gas or dispersion) which differsfrom the physical state of the active ingredient(s) introduced into theinternal periphery of the primary capsule 911 and the internal peripheryof the tertiary capsule 930.

In preferred structural design, the primary capsule 911 comprises a cap912 having a general cylindrical configuration adapted to provide asealing relationship when engaging the corresponding base 914 to form asingle dosage, multi-compartment capsule 910. An amount of fillingmaterial 940 may be introduced into at least a portion of the internalperiphery of the cap 912 to fill, either partially or completely, theinner volume of the cap, thereby reducing the dead space volume in thecap and the internal periphery of the receiving chamber 918 of the base.In this regard, the configuration of the addition of the filler material940 relative to the internal periphery of the cap 912 may generallyeliminate or substantially reduce the potential dead space volume withinthe internal periphery of the receiving chamber 918, thus functionallynegating the potential for a reaction between an air bubble and theactive ingredient(s) introduced into the base 914 of the primary capsule911.

Preferably, the filling material 940 introduced into at least a portionof the internal periphery of the cap 912 may include a hydrophilicpolymer, such as gelatin. It will be readily appreciated by thoseskilled in the art that other filling materials may be used, such as,for example, starch, casein, chitosan, soya bean protein, safflowerprotein, alginates, gellan gum, carrageenan, xanthan gum, phtalatedgelatin, succinated gelatin, cellulosephtalate-acetate,polyvinylacetate, hydroxypropyl methyl cellulose, oleoresin,polyvinylacetate-phtalate, polymerisates of acrylic or methacrylicesters, and mixtures thereof, or the like, and/or combinations thereof.In other presently preferred embodiments of the present invention, thefilling material 840 may include the introduction of an inert compound,for example, nitrogen gas into at least a portion of the internalperiphery of the cap 912. Based on the principals of eliminating orreducing the volume dead space in multi-compartment capsules disclosedherein, those skilled in the art will readily recognize other possiblemodifications and combinations which are consistent with the spirit andscope of the present invention. It is intended, therefore, that theexamples provided herein be viewed as exemplary of the principles of thepresent invention, and not as restrictive to a particular structure orprocess for implementing those principles.

The filling material 940 introduced within at least a portion of theinternal periphery of the cap 912 of the primary capsule 911 isgenerally intended to promote a binding contact with at least a portionof the cap 922 of the secondary capsule 920, thereby seating at least aportion of the secondary capsule within the cap of the primary capsuleand forming a molded appearance. As appreciated, the introduction of thefilling material 940 into the cap 912 of the primary capsule 911 priorto the joining and sealing process tends to prevent the opportunity fora reaction between an air bubble and the active medicament(s) within thereceiving chamber 918 of the primary capsule, while preserving theoverall rounded shape of the multi-compartment capsule 910 for ease ofswallowing by a consumer.

As best illustrated in FIG. 13, one presently preferred embodiment of anencapsulation process, as defined by the structural configuration of themulti-compartment capsule 910, may include the steps of: (1) introducingone or more active ingredients or medicaments (e.g., pharmaceutical,biotechnical, nutraceutical, vitamin, dietary supplement, mineral orcombination thereof) into at least a portion of the receiving chamber938 of a tertiary capsule 930; (2) selectively positioning the cap 932in sealing relationship with the base 934 of the tertiary capsule 930;(3) introducing one or more active ingredients or medicaments (e.g.,pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof), together with the tertiarycapsule 930, into at least a portion of the receiving chamber 928 of thesecondary capsule 920; (4) selectively positioning the cap 922 insealing relationship with the base 924 of the secondary capsule 920; (5)introducing one or more active ingredients or medicaments (e.g.,pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof), together with the secondarycapsule 920, into at least a portion of the receiving chamber 918 of theprimary capsule 911; (6) introducing a filling material 940 into atleast a portion of the internal periphery of the cap 912 (i.e.,preferably filling the cap); and (7) selectively positioning the cap 912having a general conical configuration in seating relationship with atleast, a portion of the secondary capsule 920 and sealing the base 914of the primary capsule 911 to form one presently preferred embodiment ofa single, dosage multi-compartment capsule 910, wherein eliminating orsubstantially reducing dead space volume within the internal peripheryof the cap 912 and the receiving chamber 918, respectively.

A solid may be introduced within at least a portion of the internalperiphery of the receiving chamber 938 of the tertiary capsule 930, aliquid may be introduced into at least a portion of the internalperiphery of the secondary capsule 920 and a solid may be selectivelyintroduced within at least a portion of the internal periphery of thereceiving chamber 918 of the primary capsule 911. Although theingredient(s) introduced into the receiving chambers 918, 928, 938 ofthe primary, secondary and tertiary capsules 911, 920, 930,respectively, may be the same or different from the ingredient(s)introduced into the other receiving chambers, the active ingredient(s)in at least two of the receiving chambers 918, 928, 938 have differentphysical states (i.e., solid, liquid, gas or dispersion). Those skilledin the art will readily recognize other possible modifications andadaptations relative to the contemplated variations in physical statesof the active ingredient(s) selectively introduced within the receivingchambers 918, 928, 938 of the primary, secondary and tertiary capsules911, 920, 930, respectively, which are consistent with the spirit andscope of the present invention. It is intended, therefore, that thefigures and examples provided herein be viewed as exemplary of theprinciples of the present invention, and not as restrictive to aparticular structure or method for implementing those principles.

Generally referring to FIGS. 1-13, the component parts of the presentlypreferred embodiments of the multi-compartment capsules (i.e., capsularbase, corresponding cap and dividing walls) of the present invention maycomprise a hydrophilic polymer, such as gelatin (marine or animal basedproduct). Other suitable materials forming the capsules may includestarch, casein, chitosan, soya bean protein, safflower protein,alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin,succinated gelatin, cellulosephtalate-acetate, polyvinylacetate,hydroxypropyl methyl cellulose (HPMC), oleoresins,polyvinylacetate-phtalate, polymerisates of acrylic or methacrylicesters, and mixtures thereof, or the like, and/or combinations thereof.The material comprising the capsular components may further includebetween about 0% to 40% of pharmaceutically acceptable plasticizersbased upon the weight of the hydrophilic polymer. Plasticizers that maybe employed include, for example and not by way of limitation,polyethylene glycol, glycerol, sorbitol, dioctyl-sodium sulfosuccinate,triethyl citrate, tributyl citrate, 1,2-propyleneglycol, mono-acetates,di-acetates, or tri-acetates of glycerol, mixtures thereof, or the like,and/or combinations thereof. As appreciated, plasticizers may also beused in the development of a soft elastic shell, often referred to as asoft gelatin capsule or “soft gel” capsule, for a primary capsule, asecondary capsule and/or a tertiary capsule.

The capsular shell material may contain pharmaceutically acceptablelubricants in the range of about 0% to 10%, based upon the weight of thehydrophilic polymer. Lubricants that may be used include, for exampleand not by way of limitation, aluminum stearate, calcium stearate,magnesiumstearate, tin stearate, talc, sodium lauryl sulfate, lecithins,mineral oils, stearic acid, silicones, mixtures thereof, or the like,and/or combinations thereof. One presently preferred embodiment of themulti-compartmental capsules of the present invention (e.g., primarycapsule, secondary capsule, tertiary capsule, etc.) may include, forexample, LICAPS® capsules (for poorly soluble compounds), VCAPS™capsules (made from cellulosic raw materials), CONI-SNAP® capsules andPRESS-FIT® capsules which are all presently manufactured by Capsugel, asubsidiary of Pfizer, Inc.

In one presently preferred embodiment of an encapsulation process, theprimary capsule may be kept under conditions of low humidity within afilling machine during the contemplated steps of rectifying andassembling. In certain embodiments, the primary capsule may containmoisture content in the range of approximately 0% to 6% of the totalweight. Similarly, a secondary capsule, a tertiary capsule, etc. may beprocessed in the same manner as the primary capsule relative toconditions of low humidity during the steps of rectifying andassembling. As contemplated herein, a moisture content of approximately0% to 3% by weight is preferable. However, capsules having a highermoisture content than those stated herein are certainly not outside thespirit and scope of the present invention.

As illustrated in FIGS. 1-9 and 11-13, the shape of the base andcorresponding cap of the capsules (e.g., primary, secondary, tertiary,etc.) of the presently preferred embodiments of the multi-compartmentcapsules are configured having a general cylindrical shape which definesa diameter and length sufficient for the introduction of an internalsmaller capsule or one or more dividing walls along the length of thecapsular base. It is apparent that other geometrical configurations ofthe cap are likewise suitable and contemplated herein, such as thegeneral U-shaped configuration of the cap shown in FIG. 10. It isintended, therefore, that the examples provided herein be viewed asexemplary of the principles of the present invention, and not asrestrictive to any particular structure or configuration forimplementing those principles.

In one presently preferred embodiment, the clearance between the primarycapsule and the secondary capsule introduced within the internalperiphery of the primary capsule is preferably greater than +0.2 mm. Theclearance between the outer capsular walls of the secondary capsule andthe inner capsular walls of the primary capsule (or the tertiary capsuleand the secondary capsule) may be in the range of about 0 mm to 0.5 mm,whereas the outer capsular walls of the secondary capsule or tertiarycapsule may be in actual contact with the inner capsular walls of theprimary capsule or secondary capsule, respectively. As appreciated, inan effort to structural facilitate independent receiving chambers onopposing sides of a dividing wall introduced within the internalperiphery of a base of a capsule, the perimeter of the dividing wallpreferably engages the inner capsular walls of the capsule to provide asealing relationship there between.

As further contemplated herein, the inner capsular walls of a primarycapsule may be treated with an adhesive sufficient to improve engagementbetween the primary capsule and the outer capsular walls of a secondarycapsule. A suitable technique to apply an adhesive may be by way ofspraying the same on the shells and capsules immediately beforeassembling the same. Suitable adhesives that may be used may include,for example, tackidex, an aqueous gelatin solution, or the like.

The primary, secondary or tertiary capsules, in accordance with thepresent invention, may be formed having the same or different colors.Moreover, the base and corresponding cap of a single capsule may beformed having different colors in an effort to enhance the aesthetics ofthe capsule to the consumer. In one presently preferred embodiment of amulti-compartment capsule of the present invention, the dosage may bebanded, sealed or easily dividable in a contact area of the primary andsecondary capsules or the sealing band may be color-coded to assist inbranding, if desired.

It is further contemplated herein that a multi-compartment capsule ofthe present invention may comprise component parts of the capsule havingvarious time-release coatings to facilitate the release and ultimatelythe absorption of those active ingredients introduced into the differentreceiving chambers of the multi-compartment capsule to release atdifferent release rates. In particular, a primary capsule may be formedhaving a conventional time-release coating that dissolves and releasesthe active ingredient(s) contained therein before the timed-release ofthe active ingredient(s) contained within a secondary capsule. Likewise,the dividing walls disposed within the internal periphery of the base ofa capsule may be formed having conventional time-release coatings thatdissolve and release the active ingredients within each receivingchamber defined by the dividing walls at different rates, therebydelivering the active ingredients or medicaments contained within amulti-compartment capsule at different rates. Certain active ingredientsor medicaments may, therefore, be delivered at a selected interval,while other ingredients may be released at a later interval. In thisway, the novel design of the multi-compartment capsules of the presentinvention may facilitate precision delivery of active ingredients totargeted areas of the consumer.

The disclosure of secondary and tertiary capsules may be replaced withother forms of microencapsulation. Microencapsulation, as previouslydescribed, refers to the process whereby minute parcels of a solid,liquid, gas or dispersion, introduced into one or more of the receivingchambers as active ingredient(s), are film-coated with a secondarymaterial in order to shield the active ingredient from its surroundingenvironment. Microcapsules may measure from microns to severalmillimeters, whereas the main purpose being to facilitate the release ofthe active ingredients at different release rates.

The incorporation of time-release coatings to varying the release ratesof the active ingredients of a multi-compartment capsule may be used totarget key time intervals or events when the body may be most able toutilize the active ingredients. In one presently preferred embodiment ofthe present invention, all of the active ingredients may bemicroencapsulated. In alternate presently preferred embodiments, onlyselected ingredients may be microencapsulated for delayed release, whileother ingredients may be provided for immediate absorption. Thus, theincorporation of time-release coatings in the encapsulation process whenforming a multi-compartment capsule may be specifically designed to fitthe needs and desires of numerous different users having similarconditions that are being targeted for treatment.

As contemplated herein, the physical states of active ingredients arecharacterized into one of four different states (e.g., solid, liquid,gas or dispersion). These four different states are sometimes referredto as “phases” (i.e., solid phase, liquid phase, gas phase or dispersionphase). For purposes of the present invention, the term “solid” isdefined as including, by way of example only and not by way oflimitation, pills, tablets, capsules (including both hard and softelastic), powders, granulation, flakes, troches (lozenges andpastilles), suppositories and semi-solid pastes, ointments, emulsions orcreams. The term “liquid” is defined as including, by way of exampleonly and not by way of limitation, solutions, spirits, elixirs, sprays,syrups or fluid extracts. The term “dispersion” is defined as including,by way of example only and not by way of limitation, aerosols (liquid orsolid in gas), suspensions (solid in liquid), emulsions (liquid inliquid), foams (gas in liquid), solid foams (solid in gas) or gels(liquid or solid in solid).

The active ingredients or medicaments introduced into the receivingchambers of the multi-compartment capsules of the present inventionpreferably comprise a pharmaceutical, biotechnical, nutraceutical,vitamin, dietary supplement, mineral or combination thereof. Forpurposes of the present invention, the term “pharmaceutical” is definedas any substance that affects the structure or functioning of a livingorganism. Pharmaceuticals, sometimes referred to as “drugs” are widelyused for the prevention, diagnosis and treatment of diseases and for therelief of symptoms. The term “biotechnical” is defined as any substancethat is derived from a biotechnology process. Biotechnology, sometimesshortened to “biotech”, is the development of techniques and methods(e.g., genetic engineering, protein engineering, genomics, proteomics,monoclonal antibody production, polymerase chain reaction, transgenicsand the like) for the application of biological processes to theproduction of materials of use in medicine, foods, nutrition andindustry. The term “nutraceutical” is defined as any substance that is afood of a part of a food and provides medical or health benefits,including the prevention and treatment of disease. The term “vitamin” isdefined as any of various organic substances or compounds that areessential for the normal processes of growth and maintenance (e.g.,essential for energy transformation and regulation of metabolism) of thebody which are present in natural foodstuffs or sometimes producedwithin the body. The term “dietary supplement” is defined as any product(other than tobacco) intended to supplement the diet that bears orcontains one or more of the following dietary ingredients: (A) avitamin; (B) a mineral; (C) an herb or other botanical; (D) an aminoacid; (E) a dietary substance for supplementing the diet by increasingthe total dietary intake; or (F) a concentrate, metabolite, constituent,extract or combination of any ingredient described in (A), (B), (C),(D), or (E) hereinabove. If desired, excipients may also be introducedinto one or more of the receiving chambers of the multi-compartmentcapsules of the present invention in addition to the activeingredient(s). For example, in some cases involving medicaments withpoor water solubility, it may be desirous to stabilize the liquids,solids or dispersions using a lipid, lipoid, lecithin, ghee or the like.Still further by example, in some cases involving active ingredients ormedicaments with poor bioavailability, bioequivalence, or otherundesirous pharmaceutical properties (e.g., poor water solubility, pHlability, physical incompatibility, chemical incompatibility,macromolecular size and the like) such as proteins (e.g., hormones,erythropoietins, colony stimulating factors, interferons, interleukins,plasminogen activators, monoclonal antibodies, vaccines, plant proteins,such as soy and other therapeutic proteins) or other non-polar orweak-polar materials, it may be desirous to complement the activeingredient or medicament in liquid, solid or dispersion form using afat, lipid, lipoid, lecithin, ghee, polymers, viral and bacterialvectors and the like.

It may be demonstrated that as medical and pharmacy knowledge hascontinued to expand exponentially, new medicaments, new classes ofmedicaments and new delivery technologies are becoming available for usein animals and humans who experience particular medical diseases,illnesses or conditions. A disease, illness, or condition may affect oneor more organ systems in an animal or human. Organ systems may include,for example: (1) autonomic, (2) cardiovascular, (3) neurological, (4)gastro-intestinal, (5) respiratory, (6) renal system, (7) psychiatric,(8) endocrine, (9) gynecologic, (10) urologic, (11) immunologic, (12)bone and joint systems, (13) ear, nose, and throat, (14) dermatologic,(15) hematologic, (16) infectious defense and (17) nutrition andmetabolism. In an animal or human who may be suffering from one disease,illness or condition, it is common to also be suffering from a disease,illness or condition affecting one or more of the other organ system(s).These concomitant diseases, illnesses or conditions occurring within asingle animal or human are often labeled as “co-morbidities,” a termoften shortened and referred to as “co-morbid.”

New medicaments and delivery technologies are providing patients andtheir health care practitioners with unprecedented therapeutic optionsin managing diseases, illnesses and conditions. In spite of thissophistication, there has been no effort to develop new methods of usingfixed combinations of medicaments for therapy of co-morbid diseases,illnesses or conditions. Moreover, there has been no effort to developnew methods of using fixed combinations of medicaments for management ofa single disease, illness or condition affecting one or more organsystem(s). The aforementioned fixed combinations may include a pluralityof medicaments, which may be newly discovered and developed, or havebeen known for sometime or some combination of medicaments thereof. Inany regard, said fixed combinations have not previously beencontemplated in the art.

The following examples will illustrate the invention in further detail.It will be readily understood that the various active ingredients ormedicaments that may be introduced into the receiving chambers of themulti-compartment capsules of the present invention, as generallydescribed and illustrated in the Examples herein, are to be viewed asexemplary of the principles of the present invention, and not asrestrictive to a particular structure or process for implementing thoseprinciples. Thus, the following more detailed description of thepresently preferred embodiments of the methods, formulations, andcompositions of the present invention, as represented in Examples I-XIVbelow, is not intended to limit the scope of the invention, as claimed,but is merely representative of presently preferred embodiments of theinvention.

Example I Glucosamine/Chondroitin (Solid) & Vitamin E (Liquid)

As appreciated by those skilled in the art, arthritis is an inflammatorycondition typically affecting the synovia membranes and cartilage ofjoints. It has been estimated that as many as one in three persons mayexperience symptoms associated with arthritis during their lifetime.

In addition to arthritis, various other chronic, debilitating conditionsmay afflict the aged. Many of these conditions result from the naturalprocess of aging in humans. The natural aging process is partially dueto the accumulation and effects of toxic free-radical chemicals.Free-radicals result from several homeostatic biochemical processes. Itis, accordingly, desirable to develop nutraceutical or dietarysupplement products which may alleviate multiple chronic, debilitatingconditions. It is also desirable to package and administer such productsin the most economic and convenient possible fashion.

The administration of glucosamine, a naturally occurring substance inmucopoly-saccharides, mucoproteins and chitin, is believed to promotethe production of cartilage components and the repair of damagedcartilage. Clinical findings support that fibroblast cells increasedproduction of mucopolysaccharide and collagen synthesis when glucosaminewas added.

Chondroitin sulfates are large polymers of glycosaminoglycans, primarilyD-glucuronic acid and D-acetylgalactosamine, and disaccharides and maybe derived from the cartilage of bovine trachea. The administration ofchondroitin sulfate has been shown to promote the formation of newcartilage matrix. In particular, chondroitin stimulates the metabolismof chondrocyte cells and the production of collagen and proteoglycan.

Vitamin E, also known as alpha-tocopherol, is a well-known scavenger offree-radicals in the body. Free-radical scavengers are sometimesreferred to as anti-oxidants. This scavenging process is important fordetoxifying the body of chemicals which are known to promote apoptosis,or programmed cell death. Apoptosis is a scientific description ofcellular destruction. Although vitamin E is a popular anti-oxidant, itis poorly soluble in water and thus can be administered only as aliquid-oil formulation or in an oil formulation enclosed in a softelastic capsule.

In one presently preferred embodiment of the present invention,therapeutically effective amounts of glucosamine, chondroitin, andvitamin E (active ingredients) may be introduced into receiving chambersof a multi-compartment capsule wherein at least two of the activeingredients have physical states (e.g., solid, liquid, gas ordispersion) that differ. Consistent with the foregoing,multi-compartment, multi-phase capsules and encapsulation technology areherein contemplated to produce a delivery vehicle for deliveringanti-arthritic and anti-oxidant compounds to the body in a singledosage. A capsular format of the present invention may include thefollowing composition:

Primary Capsule: Glucosamine HCl 500 mg [500-2000 mg/day] Chondroitinsulfate 400 mg [400-1600 mg/day] Secondary Capsule: Vitamin E 200 IU[200-400 IU/day]

The incorporation of time-release coatings to varying the release ratesof the active ingredients (e.g., glucosamine HCl/chondroitin sulfate andvitamin E) in the primary and secondary capsules, respectively, of themulti-compartment capsule may be used to target key time intervals orevents when the body may be most able to utilize the named activeingredients. Thus, the incorporation of time-release coatings in theencapsulation process when forming a multi-compartment capsule may bespecifically designed to fit the needs and desires of numerous differentusers having similar conditions that are being targeted for treatment.

A therapeutically effective amount of glucosamine HCl/chondroitinsulfate may be introduced into at least a portion of the internalperiphery of the receiving chambers of a primary capsule in the form ofa solid and a therapeutically effective amount of vitamin E may beintroduced into at least a portion of a secondary capsule in the form ofa liquid, if desired. Since the encapsulation process andmulti-compartment, multi-phase capsule of the present invention areconfigured to apply to an anticipated treatment regime or medicinaldesign of a single dosage capsule, it will be readily appreciated thatthe introduction of one or more active ingredients into the receivingchambers of the primary and secondary capsules, respectively, isanticipated such that the various ingredients may be introduced indifferent receiving chambers to accommodate different treatmentmodalities. For example, a multi-compartment capsule may be formulatedhaving glucosamine HCl and chondroitin sulfate introduced into thereceiving chambers of the secondary capsule and vitamin E may beintroduced into the receiving chamber of the primary capsule. It isintended, therefore, that the examples provided herein be viewed asexemplary of the principles of the present invention, and not asrestrictive to a particular structure or method for implementing thoseprinciples.

Example II S-Adenosylmethione (SAMe) (Solid) & Vitamin E (Liquid)

S-adenosylmethione (SAMe), may be derived from two materials;methionine, a sulfur-containing amino acid, and adenosine triphosphate(ATP), the body's main energy compound. SAMe was originally developedaround 1950 as an antidepressant. Over the years, it has also been foundthat SAMe may assist in alleviating arthritic symptoms, assist in themanufacture of melatonin, which is needed to regulate sleep, helpprotect DNA from harmful mutations and prevent certain types of nervedamage.

As noted above, vitamin E is a popular anti-oxidant, but it is poorlysoluble in water and therefore can be administered only as a liquid-oilformulation. Vitamin E is typically measured in international units (IU)of alpha tocopherol.

In one presently preferred embodiment of the present invention,therapeutically effective amounts of SAMe and vitamin E (activeingredients) may be introduced into receiving chambers of amulti-compartment capsule wherein SAMe comprises a physical state (e.g.,solid, liquid, gas or dispersion) different from the physical state ofvitamin E. As shown in FIGS. 3 and 4, a therapeutically effective amountof SAMe may be introduced into receiving chamber 218 a and atherapeutically effective amount of vitamin E may be introduced intoreceiving chamber 218 b of a multi-compartment capsule 210 of thepresent invention. Consistent with the foregoing, multi-compartment,multi-phase capsules and encapsulation technology are hereincontemplated to produce a delivery vehicle for delivering moodenhancing, anti-arthritic and anti-oxidant compounds to the body in asingle dosage. A capsular format of the present invention may includethe following composition:

Receiving Chamber (218a): S-adenosylmethione 1000 mg [200-1600 mg/day]Receiving Chamber (218b): Vitamin E  200 IU [200-400 IU/day]

The incorporation of time-release coatings to varying the release ratesof the active ingredients (e.g., SAMe and vitamin E) of themulti-compartment capsule 210 may be used to target key time intervalsor events when the body may be most able to utilize the named activeingredients. Thus, the incorporation of time-release coatings in theencapsulation process when forming a multi-compartment capsule may bespecifically designed to fit the needs and desires of numerous differentusers having similar conditions that are being targeted for treatment.

According to one presently preferred embodiment of the presentinvention, a therapeutically effective amount of SAMe may be introducedinto at least a portion of the receiving chamber 218 a in the form of asolid and a therapeutically effective amount of vitamin E may beintroduced into at least a portion of the receiving chamber 218 b of theprimary capsule 211 in the form of a liquid.

In an alternative presently preferred embodiment of the presentinvention, therapeutically effective amounts of SAMe and vitamin E(active ingredients) may be introduced into receiving chambers of amulti-compartment capsule wherein SAMe comprises a physical state (e.g.,solid, liquid, gas or dispersion) different from the physical state ofvitamin E. As shown in FIG. 2, a therapeutically effective amount ofSAMe, in the form of a solid, may be introduced into receiving chamber118 and 138 and a therapeutically effective amount of vitamin E, in theform of a liquid, may be introduced into receiving chamber 128 of amulti-compartment capsule 110 of the present invention. The materialforming the primary capsule shell 111 may be formulated in a mannerallowing for immediate dissolution and release of the of the contents ofreceiving chamber 118. The material forming the secondary capsule shell120 may be formulated in a manner allowing for either an immediatedissolution or a time-delayed dissolution and release of the contents ofreceiving chamber 128. The material forming the tertiary capsule shell138 may be formulated in a manner allowing for time-delayed dissolutionand release of the contents of receiving chamber 138. In this presentlypreferred embodiment of the present invention, a total daily dosage ofSAMe may be delivered as two separate dosages within a single oraldosage form. One presently preferred embodiment of the present inventionthus makes for a more convenient dosage form.

Since the encapsulation process and multi-compartment, multi-phasecapsule of the present invention are configured to apply to ananticipated treatment regime or medicinal design of a single dosagecapsule, it will be readily appreciated that the introduction of one ormore active ingredients into receiving chambers defined within a capsuleis anticipated such that the various ingredients may be introduced indifferent receiving chambers to accommodate different treatmentmodalities. It is intended, therefore, that the examples provided hereinbe viewed as exemplary of the principles of the present invention, andnot as restrictive to a particular structure or method for implementingthose principles.

Example III Curcumin, Holy Basil, Zinc (Solid) & Fish Oil (Omega 3 FattyAcids DHA & EPA—Liquid)

Curcumin belongs to a class of compounds derived from the turmeric rootand is a yellow-orange volatile oil. It is believed that curcumin has aninhibitory effect on carcinogenesis, which is the evolution of a normalcell into a cancerous cell. There is clinical evidence to suggestcurcumin may help to prevent stomach, colon, oral, esophageal, breastand skin cancers. Additional studies have been conducted to show thatcurcumin may be helpful in balancing cholesterol levels, protectingagainst ulcers by inhibition of gastric acid secretion and protection ofgastric mucosal tissue, and anti-inflammatory actions. In one clinicalstudy, curcumin was found to be as effective as non-steroidalanti-inflammatory drugs in the treatment of arthritis and post-operativepain.

The administration of Holy Basil (Ocimum sanctum) has been shown to havean effect on promoting peripherally mediated analgesic effects. Thisaction allows a broad range of therapeutic effects, including,anti-inflammatory, hypoglycemia, analgesic, anti-ulcer and anti-septicproperties.

As known, zinc is a mineral that occurs in animal and plant tissues andis an important co-factor for various enzyme reactions in the body, aswell as being helpful for the reproduction system, and for themanufacture of body proteins. Zinc is also an antioxidant nutrient,similar to vitamin E. There is clinical data that suggests that zinc maybe important to the prostate and other reproductive organs in the body,may help in the contractility of muscles, help stabilize blood, helpmaintain the body's alkaline balance and aid in the digestion andmetabolism of phosphorus.

Over several decades considerable evidence has been collected to suggestthat fish and fish oils are beneficial to the heart, mental health andin reducing cancer risk. The “active” components of fish oils areeicosapentaenoic acid (EPA), a polyunsaturated fatty acid with a 20carbon chain, and docosahexaenoic acid (DHA), a polyunsaturated fattyacid with a 22 carbon chain. Both active components are members of theomega-3 group of essential fatty acids and are found exclusively inmarine animals. The best sources for EPA and DHA may be fatty fish suchas herring, sardines, salmon and fresh tuna.

The recommended daily intake of EPA plus DHA is between 650 to 1000mg/day. Clinical trials have used anywhere from 1 g/day to 10 g/day, butlittle additional benefit has been observed at levels above 5 g/day ofEPA and DHA combined. The onset of beneficial effects is variable.Effects on cholesterol may occur in just a few weeks, but it may takethere (3) months or longer to see effects in degenerative diseases, suchas arthritis.

In one presently preferred embodiment of the present invention,therapeutically effective amounts of curcumin, Holy Basil, zinc and fishoil (active ingredients) may be introduced into receiving chambers of amulti-compartment capsule wherein curcumin, Holy Basil and zinc comprisea physical state (e.g., solid, liquid, gas or dispersion) different fromthe physical state of the fish oil. As shown in FIG. 2, atherapeutically effective amount of curcumin may be introduced intoreceiving chamber 138 of a tertiary capsule 130, a therapeuticallyeffective amount of Holy Basil and zinc may be introduced into receivingchamber 128 of a secondary capsule and a therapeutically effectiveamount of fish oil may be introduced into receiving chamber 118 of aprimary capsule 11 of a multi-compartment capsule 110 of the presentinvention. Consistent with the foregoing, multi-compartment, multi-phasecapsules and encapsulation technology are herein contemplated to producea delivery vehicle for delivering anti-neoplastic, anti-inflammatory,analgesic and anti-oxidant compounds to the body in a single dosage. Acapsular format of the present invention may include the followingcomposition:

Tertiary Capsule (130): Curcumin 400 mg [1200-1800 mg/day; 400 mg threetimes daily] Secondary Capsule (120): Holy Basil 2.5 gms [2.5 gramsfresh dried leaf powder/day] Zinc 15 mg [4-15 mg/day] Primary Capsule(111): Fish oil 1000 mg (Omega 3 fatty acids - DHA & EPA) [650-1000mg/day]

The incorporation of time-release coatings to varying the release ratesof the active ingredients (e.g., curcumin, Holy Basil, Zinc and fishoil) in the primary, secondary and tertiary capsules 111, 120, 130 ofone presently preferred embodiment of a multi-compartment capsule 110may be used to target key time intervals or events when the body may bemost able to utilize the named active ingredients. Thus, theincorporation of time-release coatings in the encapsulation process whenforming a multi-compartment capsule may be specifically designed to fitthe needs and desires of numerous different users having similarconditions that are being targeted for treatment.

As contemplated herein, a therapeutically effective amount of curcuminmay be introduced into at least a portion of the receiving chamber 138of the tertiary capsule 130 in the form of a solid, a therapeuticallyeffective amount of Holy Basil and zinc may be introduced into at leasta portion of the receiving chamber 128 of the secondary capsule 120 inthe form of a solid and a therapeutically effective amount of fish oilmay be introduced into at least a portion of the primary capsule 111 inthe form of a liquid. Since the encapsulation process andmulti-compartment, multi-phase capsule of the present invention areconfigured to apply to an anticipated treatment regime or medicinaldesign of a single dosage capsule, it will be readily appreciated thatthe introduction of one or more active ingredients into the receivingchambers of the primary and secondary capsules, respectively, isanticipated such that the various ingredients may be introduced indifferent receiving chambers to accommodate different treatmentmodalities. It is intended, therefore, that the examples provided hereinbe viewed as exemplary of the principles of the present invention, andnot as restrictive to a particular structure or method for implementingthose principles.

Example IV Vitamin C (Solid) & Vitamin E (Liquid)

It is believed that vitamin C plays an important role as a component ofenzymes involved in the synthesis of collagen and carnitine. A vitalrole of vitamin C, however, is believed to be that of the primary,water-soluble antioxidant in the human body. A daily intake of 60-1000mg of vitamin C may be adequate for preventive purposes, but far largerquantities may be required to have an effect on halting or reversingcancer and heart disease.

As noted above, vitamin E is a popular anti-oxidant, but it is poorlysoluble in water and therefore can be administered only as a liquid-oilformulation.

In one presently preferred embodiment of the present invention,therapeutically effective amounts of vitamin C and vitamin E (activeingredients) may be introduced into receiving chambers of amulti-compartment capsule wherein vitamin C comprises a physical state(e.g., solid, liquid, gas or dispersion) different from the physicalstate of vitamin E. Consistent with the foregoing, multi-compartment,multi-phase capsules and encapsulation technology are contemplatedherein to produce a delivery vehicle for delivering anti-oxidantcompounds to the body in a single dosage. A capsular format of thepresent invention may include the following composition:

Primary Capsule: Vitamin C 500 mg [60-1000 mg/day] Secondary Capsule:Vitamin E 200 IU [200-400 IU/day]

The incorporation of time-release coatings to varying the release ratesof the active ingredients (e.g., vitamin C and vitamin E) in differentreceiving chambers of a multi-compartment capsule may be used to targetkey time intervals or events when the body may be most able to utilizethe named active ingredients. Thus, the incorporation of time-releasecoatings in the encapsulation process when forming a multi-compartmentcapsule may be specifically designed to fit the needs and desires ofnumerous different users having similar conditions that are beingtargeted for treatment and is contemplated herein.

A therapeutically effective amount of vitamin C may be introduced intoat least a portion of a first receiving chamber in the form of a solidand a therapeutically effective amount of vitamin E may be introducedinto at least a portion of a second receiving chamber in the form of aliquid. Since the encapsulation process and multi-compartment,multi-phase capsule of the present invention are configured to apply toan anticipated treatment regime or medicinal design of a single dosagecapsule, it will be readily appreciated that the introduction of one ormore active ingredients into the receiving chambers of the primary andsecondary capsules, respectively, is anticipated such that the variousingredients may be introduced in different receiving chambers toaccommodate different treatment modalities. It is intended, therefore,that the examples provided herein be viewed as exemplary of theprinciples of the present invention, and not as restrictive to aparticular structure or method for implementing those principles.

Example V Selenium/Vitamin C (Solid) & Vitamin E/Beta-Carotene/Fish Oil(Omega 3 Fatty Acids DHA & EPA) (Liquid)

Selenium is an essential trace mineral in the human body and animportant part of antioxidant enzymes that protect cells against theeffects of free radicals that are produced during normal oxygenmetabolism. As readily known in the art, the body has developeddefenses, such as antioxidants, to assist in controlling levels of freeradicals which can cause damage to cells and contribute to thedevelopment of some chronic diseases. It is also believed that Seleniumis essential for normal functioning of the immune system and thyroidgland. The recommended dietary allowance for selenium is 55 mcg/day.

As noted above, it is believed that vitamin C plays an important role asa component of enzymes involved in the synthesis of collagen andcarnitine and a vital role as a water soluble antioxidant in the humanbody. Vitamin E is another important anti-oxidant.

Beta-carotene is a substance found in plants that the body converts intovitamin A. It is believed that beta-carotene acts as an antioxidant andan immune system booster. There is no RDA for beta-carotene. The mostcommon beta-carotene supplement intake is about 25,000 IU (15 mg) perday, however supplementation with as much as 100,000 IU (60 mg) per dayhas been reported.

It has been suggested that fish and fish oils are beneficial to theheart, mental health and in reducing cancer risk. The recommended dailyintake of EPA plus DHA (the active components of fish oil) is between650 to 1000 mg/day. Clinical trials have used anywhere from 1 g/day to10 g/day, but little additional benefit has been observed at levelsabove 5 g/day of EPA and DHA combined.

In one presently preferred embodiment of the present invention,therapeutically effective amounts of selenium, vitamin C, beta-carotene,vitamin E and fish oil (active ingredients) may be introduced intoreceiving chambers of a multi-compartment capsule wherein selenium andvitamin C comprise a physical state (e.g., solid, liquid, gas ordispersion) different from the physical state of vitamin E,beta-carotene and fish oil (omega 3 fatty acids DHA & EPA).Specifically, a therapeutically effective amount of selenium and vitaminC may be introduced into one or more receiving chambers of a primarycapsule and a therapeutically effective amount of vitamin E,beta-carotene and fish oil (omega 3 fatty acids DHA & EPA) may beintroduced into one or more receiving chambers of a secondary capsule toform a multi-compartment capsule of the present invention. Consistentwith the foregoing, multi-compartment, multi-phase capsules andencapsulation technology are herein contemplated to produce a deliveryvehicle for delivering anti-oxidant compounds to the body in a singledosage. A capsular format of the present invention may include thefollowing composition:

Primary Capsule: Selenium 50 mcg [50-100 mcg/day] Vitamin C 500 mg[60-1000 mg/day] Secondary Capsule: Beta-carotene 50 mg [30-300 mg/day]Vitamin E 200 IU [200-400 IU/day] Fish oil 1000 mg (Omega 3 fattyacids - DHA & EPA) [650-1000 mg/day]

The incorporation of time-release coatings to varying the release ratesof the active ingredients (e.g., selenium, vitamin C, vitamin E, betacarotene and fish oil) in different receiving chambers of amulti-compartment capsule may be used to target key time intervals orevents when the body may be most able to utilize the named activeingredients. Thus, the incorporation of time-release coatings in theencapsulation process when forming a multi-compartment capsule may bespecifically designed to fit the needs and desires of numerous differentusers having similar conditions that are being targeted for treatmentand is contemplated herein.

A therapeutically effective amount of selenium and vitamin C may beintroduced into one or more receiving chambers of a primary capsule insolid form and a therapeutically effective amount of vitamin E, betacarotene and fish oil may be introduced into one or more receivingchambers of a secondary capsule in the form of a liquid. Since theencapsulation process and multi-compartment, multi-phase capsule of thepresent invention are configured to apply to an anticipated treatmentregime or medicinal design of a single dosage capsule, it will bereadily appreciated that the introduction of one or more activeingredients into the receiving chambers of the primary and secondarycapsules, respectively, is anticipated such that the various ingredientsmay be introduced in different receiving chambers to accommodatedifferent treatment modalities. It is intended, therefore, that theexamples provided herein be viewed as exemplary of the principles of thepresent invention, and not as restrictive to a particular structure ormethod for implementing those principles.

Example VI Fluoxetine (Solid), S-Adenosylmethione (SAMe) (Solid) &Vitamin E (Liquid)

As appreciated by those skilled in the art, depression is a mental statecharacterized by excessive sadness. Depression is one of several formsof mood disorders. Activity in those affected with depression may beagitated and restless or slow and retarded. Those affected may also showpessimistic or despairing behavior and may have disturbances in sleep,appetite and concentration. Depression is often a co-morbid conditionwith other chronic disease states involving the neurological system,cardiovascular system, respiratory system, endocrine system,musculoskeletal system, immune system, genitourinary system and thelike. This list is should not be considered exclusive.

Administration of Fluoxetine is known by those of skill in the art toalleviate the signs and symptoms of depression. Fluoxetine belongs to aclass of compounds which are given the functional name: selectiveserotonin re-uptake inhibitors (SSRI's). This class may include, forexample: fluoxetine (PROZAC®), sertraline (ZOLOFT®), paroxetine(PAXIL®), fluvoxamine (LUVOX®), citalopram (CELEXA®) and escitalopram(LEXAPRO®). As appreciated, the foregoing list is provided herein asexemplary and should not be considered exclusive or exhaustive.

Fluoxetine is a bicyclic compound, similar in structure tophenylpropanolamine. Fluoxetine structure imparts a high selectivity forinteraction with cells of the nervous system for the function ofpreventing the re-uptake of serotonin into pre-synaptic cell storagesites. This action leads to marked increases in synaptic concentrationof serotonin and is facilitative of numerous physiological processesrequiring serotonin neurotransmission. In the pharmaceutical fieldFluoxetine is available as a hydrochloride salt (HCl).

S-adenosylmethione (SAMe), is derived from two materials: methionine, asulfur-containing amino acid, and adenosine triphosphate (ATP), thebody's main energy compound. SAMe was originally developed around 1950as an antidepressant, but it was also found to be helpful in thealleviation of arthritic symptoms. SAMe is essential for the manufactureof melatonin, which is needed to regulate sleep. It also helps toprotect DNA from harmful mutations and may help prevent certain types ofnerve damage. Current clinical research is beginning to confirm theseantidepressant qualities of SAMe.

Vitamin E, also named alpha-tocopherol, is a well-known scavenger offree-radicals in the body. Free-radical scavengers are sometimesreferred to as anti-oxidants. This scavenging process is important fordetoxifying the body of chemicals which are known to promote apoptosis,or programmed cell death. Apoptosis is a scientific description ofcellular destruction. Although it is a popular anti-oxidant, Vitamin Eis poorly soluble in water and thus can be administered only as aliquid-oil formulation or in an oil formulation enclosed in a soilelastic capsule. Vitamin E is typically measured in international units(IU) of alpha tocopherol.

In one presently preferred embodiment of the present invention,therapeutically effective amounts of Fluoxetine, SAMe and Vitamin E(active ingredients) may be introduced into receiving chambers of amulti-compartment capsule wherein Fluoxetine and SAMe comprises aphysical state (e.g., solid, liquid, gas or dispersion) different fromthe physical state of Vitamin E. As shown in FIGS. 3 and 4, atherapeutically effective amount of Fluoxetine and SAMe may beintroduced into receiving chamber 218 a and a therapeutically effectiveamount of Vitamin E may be introduced into receiving chamber 218 b of amulti-compartment capsule 210 of the present invention. Consistent withthe foregoing, multi-compartment, multi-phase capsules and encapsulationtechnology are herein contemplated to produce a delivery vehicle fordelivering mood enhancing, anti-depressant and anti-oxidant compounds tothe body in a single dosage. A capsular format of the present inventionmay include the following composition:

Receiving Chamber (218a): Fluoxetine 20 mg [20-60 mg/day]S-adenosylmethione 1000 mg [200-1600 mg/day] Receiving Chamber (218b):Vitamin E 200 IU [200-400 IU/day]

The incorporation of time-release coatings to varying the release ratesof the active ingredients (e.g., Fluoxetine/SAMe and Vitamin E) in theprimary and secondary capsules, respectively, of the multi-compartmentcapsule may be used to target key time intervals or events when the bodymay be most able to utilize the named active ingredients. Thus, theincorporation of time-release coatings in the encapsulation process whenforming a multi-compartment capsule may be specifically designed to fitthe needs and desires of numerous different users having similarconditions that are being targeted for treatment.

According to one presently preferred embodiment of the presentinvention, a therapeutically effective amount of Fluoxetine and SAMe maybe introduced into at least a portion of the receiving chamber 218 a inthe form of a solid and a therapeutically effective amount of Vitamin Emay be introduced into at least a portion of the receiving chamber 218 bof the primary capsule 211 in the form of a liquid.

In an alternative presently preferred embodiment of the presentinvention, therapeutically effective amounts of Fluoxetine and SAMe andVitamin E (active ingredients) may be introduced into receiving chambersof a multi-compartment capsule wherein Fluoxetine and SAMe comprises aphysical state (e.g., solid, liquid, gas or dispersion) different fromthe physical state of Vitamin E. As shown in FIG. 2, a therapeuticallyeffective amount of Fluoxetine and SAMe, in the form of a solid, may beintroduced into receiving chamber 118 and 138 and a therapeuticallyeffective amount of Vitamin E, in the form of a liquid, may beintroduced into receiving chamber 128 of a multi-compartment capsule 110of the present invention. The material forming the primary capsule shell111 may be formulated in a manner allowing for immediate dissolution andrelease of the of the contents of receiving chamber 118. The materialforming the secondary capsule shell 120 may be formulated in a mannerallowing for either an immediate dissolution or a time-delayeddissolution and release of the contents of receiving chamber 128. Thematerial forming the tertiary capsule shell 138 may be formulated in amanner allowing for time-delayed dissolution and release of the contentsof receiving chamber 138. In this presently preferred embodiment of thepresent invention, a total daily dosage of Fluoxetine and SAMe may bedelivered as two separate dosages within a single oral dosage form. Onepresently preferred embodiment of the present invention thus makes for amore convenient dosage form.

Since the encapsulation process and multi-compartment, multi-phasecapsule of the present invention are configured to apply to ananticipated treatment regime or medicinal design of a single dosagecapsule, it will be readily appreciated that the introduction of one ormore active ingredients into the receiving chambers of the primary andsecondary capsules, respectively, is anticipated such that the variousingredients may be introduced in different receiving chambers toaccommodate different treatment modalities. For example, amulti-compartment capsule may be formulated having Fluoxetine and SAMeintroduced into the receiving chambers of the secondary capsule andVitamin E may be introduced into the receiving chamber of the primarycapsule. It is intended, therefore, that the examples provided herein beviewed as exemplary of the principles of the present invention, and notas restrictive to a particular structure or method for implementingthose principles.

Example VII Rofecoxib (Solid) & Vitamin E (Liquid)

As appreciated by those skilled in the art, arthritis is an inflammatorycondition typically affecting the synovia and cartilage of joints. Ithas been estimated that as many as one in three persons may experiencesymptoms associated with arthritis during their lifetime.

In addition to arthritis, various other chronic, debilitating conditionsmay afflict the aged. Many of these conditions result from the naturalprocess of aging in humans. The natural aging process is partially dueto the accumulation and effects of toxic free-radical chemicals.Free-radicals result from several homeostatic biochemical processes. Itis, accordingly, desirable to develop pharmaceutical, biotechnical,nutraceutical or dietary supplement products which may alleviatemultiple chronic, debilitating conditions. It is also desirable topackage and administer such products in the most economic and convenientpossible fashion.

Anti-inflammatory agents may have many diverse therapeutic roles in thehuman body. Inflammation is the process undertaken by the body as itresponds to an injury. A typical inflammatory response involves bloodvessel dilation, increased blood flow to the site of injury, and influxof white blood cells to process and remove dead tissue. Inflammation canlead to pain and swelling at the site of injury. Medicaments used inmodulating the inflammatory response may be divided into steroid andnon-steroidal labels. The latter is more commonly identified asnon-steroidal anti-inflammatory drugs (NSAIDs).

Rofecoxib belongs to a class of NSAID compounds given the functionalname cyclo-oxygenase-2 (“COX-2”) inhibitors. This class may include, forexample: rofecoxib (VIOXX®), celecoxib (CELEBREX®), valdecoxib(BEXTRA®), and meloxicam (MOBIC®). As appreciated, the foregoing list isprovided herein as exemplary and should not be considered exclusive orexhaustive.

Rofecoxib is presently believed to inhibit the action of COX-2, anenzyme involved in the production of prostaglandins in the human body.Prostaglandins serve many diverse roles, one of which is to stimulate aninflammation mechanism in immune responses. Recently, Rofecoxib waslabeled for use in the treatment of osteoarthritis, rheumatoidarthritis, acute pain, and primary dysmenorrhea.

Vitamin E, also named alpha-tocopherol, is a well-known scavenger offree-radicals in the body. Free-radical scavengers are sometimesreferred to as anti-oxidants. This scavenging process is important fordetoxifying the body of chemicals which are known to promote apoptosis,or programmed cell death. Apoptosis is a scientific description ofcellular destruction. Although it is a popular anti-oxidant, Vitamin Eis poorly soluble in water and thus can be administered only as aliquid-oil formulation or in an oil formulation enclosed in a softelastic capsule.

In one presently preferred embodiment of the present invention,therapeutically effective amounts of Rofecoxib and Vitamin E (activeingredients) may be introduced into receiving chambers of amulti-compartment capsule wherein Rofecoxib comprises a physical state(e.g., solid, liquid, gas or dispersion) different from the physicalstate of Vitamin E. As shown in FIGS. 3 and 4, a therapeuticallyeffective amount of Rofecoxib may be introduced into receiving chamber218 a and a therapeutically effective amount of Vitamin E may beintroduced into receiving chamber 218 b of a multi-compartment capsule210 of the present invention. Consistent with the foregoing,multi-compartment, multi-phase capsules and encapsulation technology areherein contemplated to produce a delivery vehicle for deliveringanti-inflammatory and anti-oxidant compounds to the body in a singledosage. A capsular format of the present invention may include thefollowing composition:

Receiving Chamber (218a): Rofecoxib 25 mg [12.5-25 mg/day] ReceivingChamber (218b): Vitamin E 200 IU [200-400 IU/day]

The incorporation of time-release coatings to varying the release ratesof the active ingredients (e.g., Rofecoxib and Vitamin E) of themulti-compartment capsule 210 may be used to target key time intervalsor events when the body may be most able to utilize the named activeingredients. Thus, the incorporation of time-release coatings in theencapsulation process when forming a multi-compartment capsule may bespecifically designed to fit the needs and desires of numerous differentusers having similar conditions that are being targeted for treatment.

According to one presently preferred embodiment of the presentinvention, a therapeutically effective amount of Rofecoxib may beintroduced into at least a portion of the receiving chamber 218 a in theform of a solid and a therapeutically effective amount of Vitamin E maybe introduced into at least a portion of the receiving chamber 218 b ofthe primary capsule 211 in the form of a liquid.

In an alternative presently preferred embodiment of the presentinvention, therapeutically effective amounts of Rofecoxib and Vitamin E(active ingredients) may be introduced into receiving chambers of amulti-compartment capsule wherein Rofecoxib comprises a physical state(e.g., solid, liquid, gas or dispersion) different from the physicalstate of Vitamin E. As shown in FIG. 2, a therapeutically effectiveamount of Rofecoxib, in the form of a solid, may be introduced intoreceiving chamber 118 and 138 and a therapeutically effective amount ofVitamin E, in the form of a liquid, may be introduced into receivingchamber 128 of a multi-compartment capsule 110 of the present invention.The material forming the primary capsule shell 111 may be formulated ina manner allowing for immediate dissolution and release of the of thecontents of receiving chamber 118. The material forming the secondarycapsule shell 120 may be formulated in a manner allowing for either animmediate dissolution or a time-delayed dissolution and release of thecontents of receiving chamber 128. The material forming the tertiarycapsule shell 138 may be formulated in a manner allowing fortime-delayed dissolution and release of the contents of receivingchamber 138. In this presently preferred embodiment of the presentinvention, a total daily dosage of Rofecoxib may be delivered as twoseparate dosages within a single oral dosage form. One presentlypreferred embodiment of the present invention thus makes for a moreconvenient dosage form.

Since the encapsulation process and multi-compartment, multi-phasecapsule of the present invention are configured to apply to ananticipated treatment regime or medicinal design of a single dosagecapsule, it will be readily appreciated that the introduction of one ormore active ingredients into receiving chambers defined within a capsuleis anticipated such that the various ingredients may be introduced indifferent receiving chambers to accommodate different treatmentmodalities. It is intended, therefore, that the examples provided hereinbe viewed as exemplary of the principles of the present invention, andnot as restrictive to a particular structure or method for implementingthose principles.

Example VIII Diphenhydramine Hydrochloride (Solid) & Vitamin E (Liquid)

As appreciated by those skilled in the art, allergic reactions areconditions wherein the immune system is stimulated to identify,segregate and dispose of exogenous chemicals which cannot be recognizedby the body. Allergic reactions are often associated with the release ofhistamine, a chemical compound which produces changes in thepermeability of blood vessels and the accumulation of other immunesystem cells. In some circumstances, it may be desirable to modulate theamount of allergic response that is capable of being generated by theimmune system.

Diphenhydramine belongs to a class of compounds which are given thefunctional name: histamine-1 (H₁) receptor antagonists. These compoundsare more generally labeled as antihistamines. These antagonists arefurther divided according to their chemical structures. Diphenhydramineis an ethanolamine (aminoalkyl ether) derivative. Other chemicaldivisions may include, for example: ethylenediamine, propylamine,phenothiazine, piperazine. The ethanolamine division may include, forexample: diphenhydramine, clemastine, dimenhydrinate, and doxylamine. Asappreciated, the foregoing list is provided herein as exemplary andshould not be considered exclusive or exhaustive.

Antihistamines block the interaction of the neurotransmitter, histamine,with H₁ receptors located in smooth muscle linings of thegastrointestinal tract, bronchial tract and large blood vessels. Thisblocking action may lead to marked relaxation in smooth muscle tone andis facilitative of numerous physiological processes includingrespiration.

The H₁ antagonists may also be divided according to their selectivityfor central and peripheral HI receptors. A second-generation of H hasemerged in recent years. These agents have a greater selectivity forperipheral H₁ receptors. Second-generation H₁ receptor antagonists mayinclude, for example: azelastine (ASTELIN®), cetirizine (ZYRTEC®),desloratadine (CLARINEX®), fexofenadine (ALLEGRA®) and loratadine(CLARITINn®).

Vitamin E, also named alpha-tocopherol, is a well-known scavenger offree-radicals in the body. Free-radical scavengers are sometimesreferred to as anti-oxidants. This scavenging process is important fordetoxifying the body of chemicals which are known to promote apoptosis,or programmed cell death. Apoptosis is a scientific description ofcellular destruction. Although it is a popular anti-oxidant, Vitamin Eis poorly soluble in water and thus can be administered only as aliquid-oil formulation or in an oil formulation enclosed in a softelastic capsule.

In one presently preferred embodiment of the present invention,therapeutically effective amounts of Diphenhydramine and Vitamin E(active ingredients) may be introduced into receiving chambers of amulti-compartment capsule wherein at least two of the active ingredientshave physical states (e.g., solid, liquid, gas or dispersion) thatdiffer. Consistent with the foregoing, multi-compartment, multi-phasecapsules and encapsulation technology are herein contemplated to producea delivery vehicle for delivering anti-allergic and anti-oxidantcompounds to the body in a single dosage. A capsular format of thepresent invention may include the following composition:

Primary Capsule: Diphenhydramine HCl 50 mg [25-100 mg/day] SecondaryCapsule: Vitamin E 200 IU [200-400 IU/day]

The incorporation of time-release coatings to varying the release ratesof the active ingredients (e.g., Diphenhydramine and Vitamin E) in theprimary and secondary capsules, respectively, of the multi-compartmentcapsule may be used to target key time intervals or events when the bodymay be most able to utilize the named active ingredients. Thus, theincorporation of time-release coatings in the encapsulation process whenforming a multi-compartment capsule may be specifically designed to fitthe needs and desires of numerous different users having similarconditions that are being targeted for treatment.

A therapeutically effective amount of Diphenhydramine may be introducedinto at least a portion of the internal periphery of the receivingchambers of a primary capsule in the form of a solid and atherapeutically effective amount of Vitamin E may be introduced into atleast a portion of a secondary capsule in the form of a liquid, ifdesired. Since the encapsulation process and multi-compartment,multi-phase capsule of the present invention are configured to apply toan anticipated treatment regime or medicinal design of a single dosagecapsule, it will be readily appreciated that the introduction of one ormore active ingredients into the receiving chambers of the primary andsecondary capsules, respectively, is anticipated such that the variousingredients may be introduced in different receiving chambers toaccommodate different treatment modalities. For example, amulti-compartment capsule may be formulated having Diphenhydramineintroduced into the receiving chambers of the secondary capsule andVitamin B may be introduced into the receiving chamber of the primarycapsule. It is intended, therefore, that the examples provided herein beviewed as exemplary of the principles of the present invention, and notas restrictive to a particular structure or method for implementingthose principles.

Example IX Celecoxib (Solid) & Ibuprofen (Liquid)

As appreciated by those skilled in the art, arthritis is an inflammatorycondition typically affecting the synovia and cartilage of joints. Ithas been estimated that as many as one in three persons may experiencesymptoms associated with arthritis during their lifetime.

Anti-inflammatory agents may have many diverse therapeutic roles in thehuman body. Inflammation is the process undertaken by the body as itresponds to an injury. A typical inflamatory response involves bloodvessel dilation, increased blood flow to the site of injury, and influxof white blood cells to process and remove dead tissue. Inflammation canlead to pain and swelling at the site of injury. Medicaments used inmodulating the inflammatory response may be divided into steroid andnon-steroidal labels. The latter is more commonly identified asnon-steroidal anti-inflammatory drugs (NSAIDs).

Celecoxib belongs to a class of NSAID compounds given the functionalname cyclo-oxygenase-2 (“COX-2”) inhibitors. This class may include, forexample: rofecoxib (VIOXX®), celecoxib (CELEBREX®), valdecoxib(BEXTRA®), etodolac (LODINE®) and meloxicam (MOBIC®). As appreciated,the foregoing list is provided herein as exemplary and should not beconsidered exclusive or exhaustive.

Celecoxib is believed to inhibit the action of COX-2, an enzyme involvedin the production of prostaglandins in the human body. Prostaglandinsserve many diverse roles, one of which is to stimulate an inflammationmechanism in immune responses. Recently, Celecoxib was labeled by theUnited States Food and Drug Administration (FDA) for use in thetreatment of osteoarthritis, rheumatoid arthritis, acute pain, andprimary dysmenorrhea.

Ibuprofen is another NSAID and is believed to function as anon-selective inhibitor of cyclo-oxygenase. Ibuprofen has been labeledby the FDA for use in the treatment of osteoarthritis, rheumatoidarthritis, relief of mild to moderate pain and primary dysmenorrhea.Ibuprofen belongs to a class of compounds called phenyl-a-methylaceticacids, which are derived from salicylic acid. Non-selectivecyclo-oxygenase inhibitors may include, for example: ibuprofen(MOTRIN®), naproxen (NAPROSYN®), diclofenac (VOLTAREN®), flurbiprofen(ANSAID®), indomethacin (INDOCIN®), ketoprofen (ORUDIS®), ketorolac(TORADOL®), nabumetone (RELAFEN®), oxaprozrm (DAYPRO®), piroxicam(FELDENE®) and sulindac (CLINORIL®). As appreciated, the foregoing listis provided herein as exemplary and should not be considered exclusiveor exhaustive.

In one presently preferred embodiment of the present invention,therapeutically effective amounts of Celecoxib and Ibuprofen (activeingredients) may be introduced into receiving chambers of amulti-compartment capsule wherein Celecoxib comprises a physical state(e.g., solid, liquid, gas or dispersion) different from the physicalstate of Ibuprofen. As shown in FIGS. 3 and 4, a therapeuticallyeffective amount of Celecoxib may be introduced into receiving chamber218 a and a therapeutically effective amount of Ibuprofen may beintroduced into receiving chamber 218 b of a multi-compartment capsule210 of the present invention. Consistent with the foregoing,multi-compartment, multi-phase capsules and encapsulation technology areherein contemplated to produce a delivery vehicle for deliveringanti-arthritic and anti-oxidant compounds to the body in a singledosage. A capsular format of the present invention may include thefollowing composition:

Receiving Chamber (218a): Celecoxib 200 mg [200-400 mg/day] ReceivingChamber (218b): Ibuprofen 800 mg [2400-3200 mg/day]

The incorporation of time-release coatings to varying the release ratesof the active ingredients (e.g., Celecoxib and Ibuprofen) of themulti-compartment capsule 210 may be used to target key time intervalsor events when the body may be most able to utilize the named activeingredients. Thus, the incorporation of time-release coatings in theencapsulation process when forming a multi-compartment capsule may bespecifically designed to fit the needs and desires of numerous differentusers having similar conditions that are being targeted for treatment.

According to one presently preferred embodiment of the presentinvention, a therapeutically effective amount of Celecoxib may beintroduced into at least a portion of the receiving chamber 218 a in theform of a solid and a therapeutically effective amount of Ibuprofen maybe introduced into at least a portion of the receiving chamber 218 b ofthe primary capsule 211 in the form of a liquid.

In an alternative presently preferred embodiment of the presentinvention, therapeutically effective amounts of Celecoxib and Ibuprofen(active ingredients) may be introduced into receiving chambers of amulti-compartment capsule wherein Celecoxib comprises a physical state(e.g., solid, liquid, gas or dispersion) different from the physicalstate of Ibuprofen. As shown in FIG. 2, a therapeutically effectiveamount of Celecoxib, in the form of a solid, may be introduced intoreceiving chamber 128 and a therapeutically effective amount ofIbuprofen, in the form of a liquid, may be introduced into receivingchambers 118 and 138 of a multi-compartment capsule 110 of the presentinvention.

The material forming the primary capsule shell 111 may be formulated ina manner allowing for immediate dissolution and release of the of thecontents of receiving chamber 118. The material forming the secondarycapsule shell 120 may be formulated in a manner allowing for either animmediate dissolution or a time-delayed dissolution and release of thecontents of receiving chamber 128. The material forming the tertiarycapsule shell 138 may be formulated in a manner allowing fortime-delayed dissolution and release of the contents of receivingchamber 138. In this presently preferred embodiment of the presentinvention, a total daily dosage of ibuprofen may be delivered as twoseparate dosages within a single oral dosage form. One presentlypreferred embodiment of the present invention thus makes for a moreconvenient dosage form.

Since the encapsulation process and multi-compartment, multi-phasecapsule of the present invention are configured to apply to ananticipated treatment regime or medicinal design of a single dosagecapsule, it will be readily appreciated that the introduction of one ormore active ingredients into receiving chambers defined within a capsuleis anticipated such that the various ingredients may be introduced indifferent receiving chambers to accommodate different treatmentmodalities. It is intended, therefore, that the examples provided hereinbe viewed as exemplary of the principles of the present invention, andnot as restrictive to a particular structure or method for implementingthose principles.

Examples X

Some embodiments of the present invention will use one or more of thebelow ingredients in a multi-compartment capsule, combinable as would berecognized in view of the teachings of the present application incombination with the knowledge available to one of ordinary skill in theart. It is noted that the following non-limiting lists illustrateexemplary ingredients that can be used with the present invention,including the broader subclasses and classes to which they belong.

Botanicals Acerola Extracts Alfalfa Algae, Blue Green Aloe Amla AngelicaRoot Bacopa Monnieri Mucuna Pruriens Anise Seed Arnica ArtichokeAshwagandha Astragalus Ayurvedic Herbs Barberry Barley Grass BarleySprout Extract Benzoin Bilberry Bioflavonoids Bitter Melon Bitter OrangeBlack Cohosh Black Currant Black Walnut Bladderwrack Blue CohoshBlueberry Boswellia Brahmi Broccoli Burdock Butcher's Broom CalendulaCapsicum Cascara Sagrada Cat's Claw Cayenne Celery Seed CertifiedOrganic Herbs Chamomile Chapparal Chaste Berry Chicory Root ChineseHerbs Chlorella Chlorophyll Citrus Aurantium Cocoa Coriander Corn SilkCranberry Curcuminoids Damiana Dandelion Devil's Claw Diosgenin DongQuai Echinacea Elderberry Elecampane Root Ephedra Essential OilsEucalyptus Evening Primrose Eyebright Fennel Fenugreek Feverfew FlaxProducts Fo Ti Garcinia Cambogia Garlic Gentian Ginger Ginkgo BilobaGinseng (American) Ginseng (Panax) Ginseng (Siberian) Goldenseal GotuKola Grape Seed Extract Grape Skin Extract Grapefruit Seed Extract GreenFood Products Green Lipped Mussel Powder Green Tea GriffoniaSimplicifolia Guarana Guggul Gymnema Sylvestre Hawthorne Henna HerbalExtracts, Standardized Herbal Teas Hops Horehound Horse ChestnutHorsetail Hysop Ipriflavone Jojoba Oil Juniper Berries Kava Kava KelpExtract Kola Nut Kombucha Kudzu Larch Lavender Lemon Balm LicoriceExtract Linden Flowers Lobelia Maca Maitake Mushroom Marshmallow MilkThistle Molasses Mushrooms Neem Nettle Noni Nopal Oatstraw OctacosanolOlive Extract Orange Peel Extract Oregano Oil Oregon Mountain GrapeOrganic Sweeteners Parsley Passion Flower Pau d′Arco PennyroyalPeppermint Pfaffia Paniculata Pine Bark Extract Piper Longum PygeumAfricanum Quercitin Raspberry Powder Red Clover Red Raspberry ReishiMushroom Resveratrol Extract Rhubarb Root Rice Products Rose HipsRosemary Extract Sage Sarsaparilla Saw Palmetto Schizandra Seaweedextracts Senna Shatavari Shiitake Mushroom Silymarin Skullcap SlipperyElm Soy Isoflavones Soybean Products Spirulina St. John's Wort SteviaSumma Tea Tree Oil Terminalia Ajruna Tribulus Terrestris TriphalaTumeric Uva Ursi Valerian Extract Vegetable Extracts Vitex Wheat GermWhite Willow Bark Wild Cherry bark Wild Yam Witch Hazel Wormwood YarrowYellow Dock Yerba Sante Yohimbine Yucca

Extracts 20-ECD 7-9% 4-Androstenedione 99% Acetyl L-Carnitine HCl 99%Adenophora Tetraohylla Ext 5:1 Alisma Extract 10:1 Alpha Lipoic Acid 99%Angelica Root Extract Arbutin 99% Artemisia Extract 4:1 ArtichokeExtract 5%, Globe Asparagus Extract 4:1 Asparagus Powder AstragulusExtract 10:1 Astragulus Extract 4:1 Astragulus Extract 5:1 AstragulusRoot Extract 0.5% Astragulus Root Powder Atractylodes Extract 10:1 AvenaSativa Extract 10:1 Avena Sativa Extract 4:1 Barbed Skullcap Extract10:1 Barberry Extract 10% Bee Pollen Powder Beta-Sisterol 35% BilberryExtract 10:1 Bitter Melon Extract 8:1 Black Cohosh Extract 2.5% BlackCohosh Root Powder Black Pepper Extract 4:1 Black Soy Bean Extract 10:1Bone Powder Boswellia Serrata Extract 65% Broccoli Sprout Extract 10:1Buchu Leaf Powder Buplerum (Chai Hu) Extract 5:1 Burdock Root Extract4:1 Cabbage Extract 4:1 Caffeine (Natural) 86-87% Caffeine 99% CalciumCitrate Granular 21% Calcium-Pyruvate 99% Carrot Root Extract 4:1 CassiaNomame Extract 4:1 Catnip Extract 4:1 Cat's Claw (Inner Bark) PowderCauliflower Extract 4:1 Celandine (Greater) Extract 4:1 Celery SeedExtract Cetyl Myristoleate 11% Cetyl Myristoleate 20% ChaenomelesExtract 4:1 Chamomile Flower Extract 10:1 Chamomile Flower Extract 4:1ChasteTree Berry Extract 4:1 Chitin Chitosan 80% Chitosan 90%Chondroitin Sulfate 90% Chrysin 99% Cinnamon Powder Cistanches Extract5:1 Citrus Aurantium Extract 6% Citrus Bioflavonoid Complex 13% CitrusPeel Extract 5:1 Clove Extract 5:1 Clove Powder Coca Extract 4:1Codonopsis Pilosula Extract 5:1 Colostrum Common Peony Extract 8:1Cordyceps Extract 7% Cornsilk Extract 4:1 Cornsilk Powder CorydalisExtract 10:1 Cranberry Extract 4:1 Cranberry Powder Curcumin Extract 95%Cuscuta Extract 5:1 Damiana Extract 4:1 Damiana Leaves Powder DandelionPowder Dandelion Root Extract 6:1 Danshen Extract 80% D-CalciumPantothenate Devil's Claw Extract 2.5% Devil's Claw Extract 4:1 Devil'sClaw Root Powder DHEA 99% Diosgenin 95% DL-Phenyl Alanine DMAEBitartrate Dong Quai Extract 10:1 Dong Quai Extract 4:1 Dong Quai RootPowder D-Ribose Echinacea Angustifolia Extract 4:1 Echinacea Leaf PowderEchinacea Purpurea Extract 10:1 Echinacea Purpurea Extract 4% EchinaceaPurpurea Extract 4:1 Echinacea Purpurea Root Powder Elder Flower Extract4:1 Elderberry Extract 20:1 Elderberry Extract 4:1 Epimedium Extract 10%Epimedium Extract 10:1 Epimedium Extract 4:1 Epimedium Extract 5%Epimedium Powder Eucommia (Du Zhong) Extract 5:1 Fennel Seed Extract 4:1Fennel Seed Powder Fenugreek Extract 4:1 Fenugreek Extract 6:1 FeverfewExtract 5:1 Fisetin Fish Oil Powder Forbidden Palace Flower Extract 5:1Forskolin 8% Fo-Ti Extract 12:1 Fo-Ti Extract 8:1 Fo-Ti Powder GardeniaExtract 8:1 Garlic Extract 4:1 Garlic Powder Gentian Root Extract 6:1Ginger Extract 4:1 Ginger Root Extract 5% Ginger Root Powder GinkgoBiloba Extract 8:1 Ginkgo Extract 24/6% Ginkgo Extract 24/6%<5 GinkgoExtract 24/7% Ginkgo Leaf Extract 4:1 Ginkgo Leaf Powder Ginseng(Korean) Powder Ginseng (Panax) Extract 5% Ginseng (Panax) Extract 8%Ginseng (Panax) Extract 80% Glucomannans Konjac Powder Glucosamine HCl95% Granulation Glucosamine HCl 99% Glucsosamine Sulfate PotassiumGlucsosamine Sulfate Sodium 95% Granulation Glucsosamine Sulfate Sodium99% Goldenrod Extract 4:1 Goldenrod Powder Goldenseal Root Extract 14%Goldenseal Root Powder Gotu Kola Extract 16% Gotu Kola Extract 4:1 GotuKola Extract 8:1 Gotu Kola Powder Grape Fruit Powder Grape Seed GrapeSeed Extract 10:1 Grape Seed Extract 20:1 Grape Seed Extract 4:1 GrapeSeed Extract 5:1 Grape Seed Extract 95% Grape Seed Powder Grape SkinExtract 20:1 Grape Skin Extract 4:1 Grass-Leaved Sweetflai Extract GreenLip Mussel Extract Green Tea Extract 30% Green Tea Extract 4:1 Green TeaExtract 95% Guarana Seed Extract 10% Guarana Seed Extract 22% GuaranaSeed Extract 25% Guggul Extract 10% Guggul Extract 2.5% GugulipidExtract 10% Gymnema Sylvestre Extract 25% Gymnema Sylvestre PowderHawthorne Berry Extract 4:1 Hawthorne Berry Powder Hawthorne LeafExtract 2% Hearbacious Peony Extract 5:1 Hesperidin Extract 98%Honeysuckle Herb Extract 4:1 Hops Flower Extract 4:1 Horehound Extract10:1 Horehound Extract 4:1 Horehound Herb Powder Horse Chestnut Extract20% Horse Chestnut Extract 4:1 Horse Chestnut Powder Horsetail Extract7% Horsetail Powder Houttuynia Cordata Extract 5:1 Hydrangea Extract 8:1Hydroxy Apatite Hyssop Extract 4:1 Indole-3-Carbinol 99% IsodonGlaucocalyx Extract 10:1 Japanese Knotweed Extract Jiaogulan Extract 4:1Jin Qian Can Extract 4:1 Jingjie Extract 4:1 Jujube Fruits Extract 4:1Kava Kava Extract 30% Kava Kava Powder Kelp Extract 4:1 Kelp PowderKidney Bean Extract 10:1 Kidney Bean Pole 4:1 Kidney Bean Pole 8:1Kidney Bean Powder Kola Nut Extract 10% Kudzu Extract 4:1 Kudzu Extract6:1 Lettuce Extract 4:1 L-Glutamine L-Glycine Licorice Extract 10%Licorice Extract 5:1 Licorice Powder Lotus Leaf Powder L-Tyrosine LyciumFruit Extract 4:1 Lycium Fruit Extract 5:1 Ma Huang Extract 6% Ma HuangExtract 8% Maca Extract 0.6% Maca Extract 4:1 Maca Root Powder MagnesiumStearate Magnolia Bark Powder Magnolia Officinal Extract 4:1 MaitakeMushroom Extract 4:1 Marigold Extract (Lutein 5%) Methozyisoflavone 99%Methylsufonylmethane 99% Milk Thistle Extract 4:1 Milk Thistle SeedExtract 80% silymarin Morinda Extract 5:1 Motherwort Extract 4:1Motherwort Powder Mucuna Pruriens Extract (15% L-Dopa) Muira PuamaExtract 12:1 Muira Puama Extract 4:1 Muira Puama Powder Mushroom Extract10:1 (feishi) Mustard Seed Extract 8:1 Myrobalan Extract 4:1 Myrrha GumExtract 2.5% N-Acetyl-D-Glucosamine N-Acetyl-L-Cysteine Nettle Extract7% Nettle Leaf Extract 4:1 Nettle Leaf Powder Noni Powder Olive LeafExtract 18% Olive Powder Orange Peel Extract 4:1 Orange Peel PowderOroxylum Indicum Extract 4:1 Oroxylum Indicum Powder Oyster Meat PowderOyster Shell Powder Papaya Fruit Extract 4:1 Parsley Extract 10:1Parsley Extract 4:1 Parsley Leaf Extract 4:1 Parsley Powder PassionFlower Extract 4:1 Passion Flower Powder Pau D′Arco Powder PeppermintExtract 4:1 Peppermint Powder Perilla Seed Extract 4:1 PeriwinkleExtract 4:1 Pharbitidis Extract 4:1 Phosphatidyl Serine 20% Pine BarkExtract 4:1 Plantago Asiatica Leaf Extract 5:1 Polygala TenoifoliaExtract 4:1 Polygonum Extract Polygonum Extract 4:1 Pregnenolone 99%Propolis Extract 3% Pseudoginseng Extract Psyllium extract 4:1 PumpkinSeed Extract 4:1 Purple Willow Bark Extract 4:1 Purslane Herb Extract4:1 Pygeum Extract 4:1 Quercetin Radish Extract 4:1 Radix IsatidisExtract 4:1 Radix Polygoni Extract 4:1 Red Clover Extract 4:1 Red PepperExtract 4:1 Red Yeast Rice Red Yeast Rice Extract 10:1 Red Yeast RicePowder Rehmannia Root Extract 4:1 Reishi Mushroom Extract 4:1 RhodiolaRosea Extract 4:1 Rhododendron Extract 4:1 Rhododendron Powder RhubarbExtract 4:1 Rhubarb Root Powder Riboflavin (B2) Rice Powder RosemaryExtract 20% Rumex Madaid Extract 4:1 Salvia Extract 10:1 Salvia Extract4:1 SAMe Saw Palmetto Extract 25% Saw Palmetto Extract 25% Saw PalmettoExtract 25% Saw Palmetto Extract 4:1 Saw Palmetto Extract 45-50% SawPalmetto Oil 85-95% Saw Palmetto Powder Schizandra Extract 10:1Schizandra Extract 4:1 Scopolia Acutangula Powder Sea Cucumber PowderSenna Leaf Powder Sesame (Black) Seed Powder Shark Cartilage PowderShitake Mushroom Extract Siberian Ginseng Extract 0.8% Siberian GinsengExtract 4:1 Siberian Ginseng Powder Skullcap Extract 4:1 SkullcapExtract 4:1 Slippery Elm Powder Sodium-Pyruvate 99% Songaria CynomoriumExtract 4:1 Songaricum Powder Spirulina Powder St. John's Wort Extract0.3% St. John's Wort Extract 4:1 St. John's Wort Powder Stanol 50%Stephania Extract 4:1 Stevia Extract 4:1 Sulfate N+ Suma Root Extract4:1 Suma Root Powder Taurine Powder Thorowax Extract 4:1 Tomato ExtractTomato Extract (0.2% Lycopene) (trans)-Resveratrol 20-25% TribulusExtract 10:1 Tribulus Extract 40% Tribulus Powder Trifal Extract 4:1Turmeric Extract 4:1 Turmeric Root Powder Uva Ursi Extract 4:1 Uva UrsiPowder Valerian Root Extract 0.8% Valerian Root Extract 4:1 ValerianRoot Powder Vinca Major Seed Extract 10:1 White Wax Extract 4:1 WhiteWillow Bark 15% (total salicins) White Willow Bark 20% White Willow Bark25% White Willow Bark Extract 4:1 White Willow Bark Powder Wild YamExtract 10:1 Wild Yam Extract 16% Wild Yam Extract 4:1 Wild Yam Extract6% Wild Yam Powder Williams Elder Extract 4:1 Wolfberry Fruit Extract10:1 Wolfiporia Extract 8:1 Yellow Dock Root Extract 4:1 Yerba MateExtract (2% caffeine) Yerba Mate Extract 4:1 Yohimbe Bark Extract 15:1Yohimbe Bark Extract 2% Yohimbe Bark Extract 3% Yohimbe Bark PowderYucca Extract 4:1

Enzymes Alpha Galactosidase Amylase Bromelain Cellulase Papain PeptidaseProtease Proteolytic Enzymes Superoxide Dismutase Trypsin

Phospholipids Lecithin Phosphatidyl Choline Phosphatidyl Serine

Specialty Nutraceuticals 5-Hydroxytryptophan Acetyl L-Carnitine AlphaLipoic Acid Alpha-Ketoglutarates Bee Products Betaine HydrochlorideBovine Cartilage Caffeine Cetyl Myristoleate Charcoal Chitosan CholineChondroitin Sulfate Coenzyme Q10 Collagen Colostrum CreatineCyanocobalamin (Vitamin B12) DMAE Fumaric Acid Germanium SesquioxideGlandular Products Glucosamine HCL Glucosamine Sulfate HMB (HydroxylMethyl Butyrate) Immunoglobulin (Immune System Support) Lactic AcidL-Carnitine Liver Products Malic Acid Maltose-anhydrous Mannose(d-mannose) MSM Other Carnitine Products Phytosterols Picolinic AcidPyruvate Red Yeast Extract SAMe Selenium Yeast Shark CartilageTheobromine Vanadyl Sulfate Velvet Deer Antler Yeast

Herbal Oils Aloe Vera Artichoke Oil Artichoke Oil Black Currant Seed Oil14% GLA Black Currant Seed Oil 15% GLA Borage Oil 20% GLA Borage Oil 22%GLA Boswellia Serrata Oil CLA Conjugated Linolic Acid Evening PrimroseOil 10% GLA 75% min. Evening Primrose Oil 9% GLA Flax Seed Oil 50% ALAGarlic Oil Grape Seed Oil Guggul Lipid Oil Olive Leak Extract OreganoOil Perilla Oil 60% ALA Pumpkin Seed Oil Pygeum Oil Rosehip Oil RosemaryOil Saw Palmetto Oil Sterols Tocotrienol Palm Oil Walnut Oil Wheat GermOil Sesame Seed Oil Dill Seed Oil Clove Bud Oil Ginger Root Oil CinnamonLeaf Oil Fennel Seed Oil Curcuma Longa Oil Cummin Seed Oil Celery SeedOil Coriander Seed Oil Red Rasberry Seed Oil Cranberry Seed OilBlackberry Seed Oil

Marine Oils Cod Liver Oil (1000 A/100 D) Cod Liver Oil (2500A/250D) FishOil 30% EPA/20% DHA Fish Oil Concentrated Fish Oil Deodorized MarineLipid Oil 18/12 Marine Lipid Oil 30/20 Marine Lipid Oil 36/24 Salmon Oil18% EPA/12% DHA Squalene Oil (Shark)

Other Oils Alpha Lipoic Acid Cetyl Myristoleate CM Coenzyme Q10 LecithinMedium Chain Triglycerides MCT

Vitamins Ascorbic Acid (Vitamin C) B Vitamins Biotin Fat SolubleVitamins Folic Acid HCA (Hydroxycitric Acid) Inositol Mineral AscorbatesMixed Tocopherols Niacin (Vitamin B3) Orotic Acid PABA(Para-Aminobenzoic Acid) Pantothenates Pantothenic Acid (Vitamin B5)Pyridoxine Hydrochloride Riboflavin (Vitamin B2) (Vitamin B6) SyntheticVitamins Thiamine (Vitamin B1) Tocotrienols Vitamin A Vitamin D VitaminE Vitamin F Vitamin K Vitamin Oils Vitamin Premixes Vitamin-MineralPremixes Water Soluble Vitamins

Carotenoids Apocarotenal Astaxanthin Beta-Carotene CanthaxanthinCarotenoids Lutein/Lutein Esters Lycopene Zeaxanthin

Hormones 7-Keto-DHEA Androstenedione DHEA Melatonin Nor-AndrostenedionePregnenolone Progesterone 19 Nor-4-Androstendiol 19Nor-4-Androstenedione 19 Nor-5-Androstenediol 19 Nor-5-Androstendione3-Indolebutyric Acid 4 Androstendiol 4 Androstendione 6Furfurylaminopurene 6-Benzylaminopurine

Minerals Boron Calcium Chelated Minerals Chloride Chromium CoatedMinerals Cobalt Copper Dolomite Iodine Iron Magnesium Manganese MineralPremixes Mineral Products Molybdenum Other Minerals Phosphorus PotassiumSelenium Sodium Specialty Minerals Trace Minerals Vanadium Zinc MalicAcid Pyruvate

Probiotics Acidophilus Bifido Bacteria Lactobacillus

Proteins/Amino Acids Amino Acids Betaine Casein Functional Soy GlutamicAcid L-Alanine L-Arginine L-Cysteine L-Glutamine L-Glycine L-HistidineL-Isoeucince L-Leucine L-Lysine L-Methionine L-Ornithine L-PhenylalalineL-Proline L-Taurine L-Threonine L-Tryptophan L-Tyrosine L-ValineN-Acetly-L-Cysteine Protein Soluble Soy Soy Protein Isolates TexturedSoy Whey Protein Isolates

Specialty Nutrients ATP Forskolin Sterol Esters Stanol Esters ProbioticsLactoferin Lutein Esters Zeaxanthin Immunoglobulins IpriflavoneIsoflavones Fructo-Oligo-Saccharides Inulin Huperzine A MelatoninMedicinal Mushrooms Bile Products Peptone Products Glandular ProductsPancreatic Products Thyroid Products Ribose Probiotics

Oleo Resins Dill Seed Oleo Resin Black Pepper Oleoresin CapsicumOleoresin

Examples XI

The present invention further contemplates the use of any activeingredients or medicaments known in the art. In this regard, it is wellwithin the purview of the skilled artisan to select a particularcombination of active ingredients or medicaments. The followingnon-limiting lists illustrate exemplary active ingredients ormedicaments and the broader subclasses and classes to which they belongfor use in this invention.

Medicaments Acting on the Autonomic Nervous System

-   -   Adrenergic Medicaments    -   Cholinergic Medicaments    -   Direct Muscarinic Agonists Choline Esters        -   acetylcholine        -   bethanechol (Urecholine)        -   carbachol        -   methacholine (Provocholine)    -   Alkaloids        -   muscarine        -   pilocarpine (Pilocar)    -   Direct Nicotinic Agonist        -   nicotine    -   Acetylcholinesterase Inhibitors Acetylcholinesterase Inhibitors        (“Reversible”)        -   edrophonium (Tensilon)        -   neostigmine (Prostigmin)        -   physostigmine (Antilirium)    -   Acetylcholinesterase Inhibitors (“Irreversible”)        -   (diisopropylflurorphosphate DFP)        -   echothiophate (Phospholine)        -   isofluorophate (Floropryl)    -   Muscarinic Antagonists Atropine        -   ipratropium (Atrovent)        -   pirenzepine        -   scopolamine    -   2-PAM: Acetylcholinesterase Reactivator Pralidoxime (Protopam)        {2-PAM)}: peripheral acetyleholinesterase reactivator for        certain phosphoryl-enzyme complexes    -   Ganglionic Blockers        -   hexamethonium        -   mecamylamine (Inversine)        -   trimethaphan    -   Catecholamines        -   dobutamine (Dobutrex)        -   dopamine (Intropin)        -   epinephrine        -   isoproterenol (Isuprel)        -   norepinephrine (Levophed)    -   Direct Adrenoceptor Agonist Medicaments        -   albuterol (Ventolin, Proveritil)        -   clonidine (Catapres)        -   methoxamine (Vasoxyl)        -   oxymetazohne (Afrin)        -   phenylephrine (Neo-Synephrine)        -   ritodrine (Yutopar)        -   salmeterol (Serevent)        -   terbutaline (Brethine)    -   Indirect-Acting Sympathomimetic Medicaments        -   amphetamine        -   cocaine        -   ephedrine, Pseudoephedrine tyramine    -   Alpha-Adrenoceptor Antagonists Medicaments        -   doxazosin (Cardura)        -   labetalol (Trandate, Normodyne)        -   phenoxybenzamine (Dibenzyline)        -   phentolamine (Regitine)        -   prazosin (Minipress)        -   terazosin (Hytrin)        -   tolazoline (Priscoline)        -   trimazosin        -   yohimbine (Yocon)    -   δ-Adrenoceptor antagonist Medicaments        -   atenolol (Tenormin)        -   butoxamine        -   esmolol (Brevibloc)        -   labetalol (Trandate, Normodyne)        -   metoprolol (Lopressor)        -   nadolol (Corgard)        -   pindolol (Visken)        -   propranolol (Inderal)        -   timolol (Blocadren)    -   Adrenergic Neuron Blocking Medicaments    -   guanethidine (Ismelin)    -   reserpine

Cardiovascular System Disorders

-   -   Cardiovascular testing and diagnosis    -   Hypertension (HTN)    -   Heart Failure    -   Ischemic Heart Disease    -   Myocardial Infarction    -   Arrhythmias    -   Isolated Diastolic Heart Failure and Cardiomyopathies    -   Cardiac Transplantation    -   Venous Thromboembolism    -   Stroke    -   Hyperlipidemia    -   Peripheral vascular disease    -   Diuretics        -   carbonic-anhydrase inhibitors        -   loop diuretics        -   osmotic diuretics        -   potassium sparing diuretics        -   thiazide diuretics    -   Antiarrhythmic Medicaments        -   Sodium Channel blocking agents        -   isopyramide (Norpace)        -   flecainide (Tambocor)        -   ibutilide        -   lidocaine (Xylocaine)        -   mexiletine (Mexitil)        -   moricizine (Ethmozine)        -   procainamide (Pronestyl, Procan)        -   propafenone (Rythmol)        -   quinidine        -   tocainide (Tonocard)    -   Calcium Channel blocking agents        -   bepridil (Vasocor)        -   diltiazem (Cardizem)        -   verapamil (Isoptin, Calan)    -   Adrenergic receptor antagonists        -   propranolol (Inderal)    -   Other medicaments        -   adenosine (Adenocard)        -   amiodarone (Cordarone)        -   bretylium (Bretylol)        -   disopyramide (Norpace)        -   esmolol (Brevibloc)        -   sotalol (Betapace)    -   Hypolipidemic medicaments        -   HMG CoA Reductase Inhibitors            -   atorvastatin (Lipitor)            -   cerivistatin (Baycol)            -   lovastatin (Mevacor)            -   pravastatin (Pravochol)            -   simvastatin (Zocor)    -   Bile-acid sequestrants        -   cholestyramine (Questran)        -   colestipol (Colestid)    -   Fibric acids        -   clofilbrate        -   fenofibrate (Tricor)        -   gemfibrozil (Lopid)        -   niacin, nicotinic acid        -   probucol (Lorelco)

Antihypertensive Medicaments

-   -   Adrenergic receptor antagonists        -   acebutalol (Sectral)        -   atenolol (Tenormin)        -   betaxolol (Betoptic)        -   bisoprolol (Zebeta)        -   carteolol (Cartrol)        -   clonidine (Catapres)        -   labetalcl (Normodyne)        -   metoprolol (Toprol)        -   penbutalol (Levatol)        -   pindolol (Visken)        -   prazosin (Minipres)        -   propranolol (Inderal)        -   terazosin (Hytrin)        -   timolol (Timoptic)    -   Calcium Channel Antagonists        -   amlodipine (Norvase)        -   diltiazem (Cardizem)        -   felodipine (Plendil)        -   isradipine (Dynacirc)        -   nicardipine (Cardene)        -   nifedipine (Procardia)        -   nimodipine (Nimotop)        -   nisoldipine (Sular)        -   veraparnil (Isoptin, Catan)    -   Angiotensin Converting Enzyme (ACE) Inhibitor        -   benazepril (Lotensin)        -   bepridil (Vascor)        -   captopril (Capoten)        -   enalapril (Vasotec)        -   fosinopril (Monopril)        -   lisinopril (Prinivil, Zestril)        -   moexipril (Univasc)        -   quinapril (Accupril)        -   ramipril (Altace)    -   Angiotensin II Receptor Antagonists        -   losartan (Cozaar)        -   valasartan (Diovan)    -   Diuretics        -   amiloride (Midamor)        -   bumetanide (Bumex)        -   chlorothalidone (Hygroton)        -   ethacrynic acid (Edecrin)        -   furosemide (Lasix)        -   hydrochlorothiazide (Diuril)        -   indapamide (Lozol)        -   metolazone (Zaroxolyn)        -   torsemide (Demadex)        -   triamterene    -   Other Agents        -   hydralazine (Apresoline)        -   minoxidil (Rogaine)        -   nitroprusside (Nipride)        -   prazosin (Minipres)        -   reserpine        -   sotalol (Brevibloc)        -   spironolactone (Aldactone)        -   terazosin (Hytrin)    -   Antianginal medicaments        -   Organic nitrates        -   Calcium Channel Antagonists        -   Adrenergic Receptor Antagonists        -   amyl nitrite        -   erythrityl tetranitrate        -   isosorbide dinitrate (Isordil)        -   nitroglycerin        -   pentaerythritol tetranitrate    -   Congestive Heart Failure Medicaments        -   phosphodiesterase (PDE) inhibitors            -   amrinone (Inocor)            -   milrinone (Primacor)        -   carvedilol (Coreg)        -   cardiac glycosides            -   digitoxin            -   digoxin        -   diuretics        -   ACE Inhibitors        -   Dobutanmine        -   dopamine

Respiratory System Disorders

-   -   Asthma    -   Chronic Obstructive Lung Disease (COLD)/Chronic Obstructive        Pulmonary    -   Disease (COPD)    -   Acute Respiratory Distress Syndrome (ARDS)    -   Drug-Induced Pulmonary Disease    -   Cystic Fibrosis    -   Corticosteroids        -   beclomethasone        -   betamethasone        -   cortisone        -   dexamethasone        -   fluticasone (Flovent/Flonase)        -   hydrocortisone        -   methylprednisolone        -   prednisolone        -   prednisone        -   triamcinolone    -   sympathomimetics        -   albuterol (Proventil/Ventolin)        -   salmeterol (Serevent)    -   muscarinic antagonists        -   ipratropium (Combivent)    -   leukotriene pathway inhibitors        -   montelukast (Singulair)        -   zafirtukast (Accolate)    -   mast cell stabilizers        -   cromolyn (Intal)    -   methylxanthines        -   theophylline        -   aminophylline    -   Dnase (Pulmozyme)

Gastrointestinal System Disorders

-   -   Gastro-esophageal Reflux Disease (GERD)    -   Peptic Ulcer Disease    -   Inflammatory Bowel Disease    -   Nausea and Vomiting    -   Diarrhea, Constipation, Irritable Bowel Disease (IBD)    -   Portal Hypertension and Cirrhosis    -   Drug-Induced Liver Disease    -   Pancreatitis    -   Viral Hepatitis    -   Liver Transplantation    -   Histamine-2 receptor antagonists        -   famotidine (Pepcid)        -   nizatidine (Axid)        -   pantoprazole (Protonix)        -   rabeprazole (Aciphex)        -   ranitidine (Zantac)    -   Proton Pump Inhibitors (PPIs)        -   esomeprazole (Nexium)        -   lansoprazole (Prevacid)        -   omeprazole (Prilosec)    -   Anti-nausea/anti-vertigo medicaments        -   anticholinergics            -   antihistamines (Histamine-1 receptor antagonists)            -   dopa mine antagonists            -   prokinetic gastric stimulant            -   serotonin 5HT₃ receptor antagonists                -   dolasetron (Anzmet)                -   granisetron (Kytril)                -   ondansetron (Zofran)        -   other medicaments            -   hydroxyzine (Atarax, Vistaril)            -   corticosteroids            -   benzodiazepines            -   cannabinoids    -   Prokinetic gastric stimulants (gastric motility stimulants)        -   cisapride (Propulsid))        -   metoclopramide (Reglan)    -   Laxatives        -   Saline laxatives        -   magnesium salts        -   sodium salts    -   irritant/stimulant medicaments        -   cascara        -   senna        -   phenolphthalein        -   bisacodyl        -   casanthranol        -   castor oil    -   bulk-producing medicaments        -   methylcellulose        -   psyllium        -   polycarbophil    -   lubricant        -   mineral oil    -   surfactants        -   docusate    -   miscellaneous        -   glycerin            -   lactulose    -   Anti-diarrheal medicaments        -   diphenoxylate        -   atropine        -   diphenoxin        -   loperamide        -   bismuth        -   lactobacillus    -   Ulcerative Colitis Medicaments        -   mesalamine        -   olsalazine

Renal System Disorders

-   -   Acute Renal Failure        -   Progressive Renal Failure/Chronic Renal Failure

Neurologic System Disorders

-   -   Multiple Sclerosis and inflammatory polyneuropathies    -   Epilepsy    -   Parkinson's disease and Movement Disorders    -   Pain management    -   Headache    -   Amyotrophic Lateral Sclerosis    -   Anti-epileptic medicaments        -   carbamazepine (Tegretol)        -   divalproex sodium (Depakote)        -   felbamate (Felbatol)        -   gabapentin (Neurontin)        -   lamotrigine (Lamictal)        -   oxcarbazepine (Trileptal)        -   phenytoin (Dilantin)        -   topiramate (Topamax)        -   zonisamide (Zonegran)    -   Antimigraine medicaments        -   Serotonin 5HT₁d receptor agonists        -   almotriptan (Axert)        -   frovatriptan (Frova)        -   naratriptan (Amerge)        -   rizatriptan (Rizalt)        -   sumatriptan (Imitrex)        -   zolmitriptan (Zomig)    -   ergot alkaloids        -   dihydroergotamine (DHE)        -   isometheptine/dichlorophenazone (Midrin)        -   caffeine        -   pizotifen (Sanomigran)    -   Sedative-hypnotic Medicaments        -   benzodiazepines            -   alprazolam (Xanax)            -   clonazepam (Kloriopin)            -   clorazepate (Tranxene)            -   diazepam (Valium)            -   flumazenil (Romazicon)—antagonist            -   lorazepam (Ativan)            -   midazolam (Versed)            -   triazolam (Halcion)        -   barbiturates/Anesthetics    -   pentobarbital (Nembutal)        -   Phenobarbital (Luminal)        -   thiopental (Pentothal)    -   non-depressant anxiolytic        -   buspirone (BuSpar)    -   Treatment of alcoholism        -   disulfiram (Antabuse)    -   Pain Management Medicaments        -   Opioids            -   Opioid Peptides                -   beta-endorphin                -   dynorphin                -   enkephalins            -   Agonists                -   codeine                -   etorphine                -   fentanyl (Sublimaze)                -   hydrocodeine                -   hydromorphone                -   meperidine (Demerol)                -   methadone (Dolophine)                -   morphine                -   oxycodone                -   propoxyphene            -   Agonist-antagonists                -   buprenorphine            -   Partial Agonist                -   dezocine (Dalgan)                -   nalbuphine (Nubain)                -   pentazocine (Talwain)            -   Antagonist                -   naloxone (Narcan)        -   Non-opiate            -   acetaminophen (tylenol)            -   tramadol (ultram)    -   Anti-Parkinsonism Medicaments        -   levodopa        -   carbidopa        -   bromocriptine (Parlodel)        -   pergolide (Permax)        -   amantadine (Symmetrel)        -   selegiline (Deprenyl)        -   anticholinergic agents        -   dopamine Agonists            -   pramipexole (Mirapex)            -   ropinirole (Requip)        -   COMT inhibitors            -   entacapone (Comtan)            -   tolcapone (Tasmar)    -   Anti-Spasticity Medicaments        -   baclofen (Lioresal)        -   botulinum toxin type A (Botox)        -   carisoprodol (Soma, Rela)        -   chlorphenesin (Maolate)        -   chlorzoxazone (Paraflex)        -   cyclobenzaprine (Flexeril)            -   dantrolene (Dantrium)            -   diazepam (Valium)            -   metaxalone (Skelaxin)            -   methocarbamol (Robaxin)            -   orphenadrine (Nor-flex)            -   tizanidine (Zanaflex)

Psychiatric System Disorders

-   -   Childhood psychiatric disorders        -   Attention Deficit Hyperactivity Disorder (ADHD)/Attention            Deficit Disorder (ADD)        -   Eating disorders        -   Alzheimer's disease and Dementia Disorders        -   Substance abuse and Addictive Disorders            -   alcohol, tobacco and caffeine abuse        -   Schizophrenia        -   Depressive disorders        -   Bipolar disorders        -   Anxiety disorders        -   Obsessive-Compulsive disorders        -   Sleep disorders        -   Psychostimulant Medicaments            -   amphetamine mixed salts (Adderall)            -   dextroamphetamine (Dexedrine)            -   methylphenidate (Ritalin, Concerta)        -   Antipsychotic Medicaments (dopamine antagonists)            -   Phenothiazine type                -   chlorpromazine (Thorazine)                -   fluphenazine (Prolixin)            -   Thioxanthene type                -   thiothixene (Navane)            -   Butyrophenone type                -   haloperidol (Haldol)            -   Dibenzodiazepine type                -   clozapine (Clozaril)            -   Thienobenzodiazepine type                -   olanzapine (Zyprexa)                -   quetiapine (Seroquel)        -   Antidepressant Medicaments            -   Tricyclic antidepressants (TCA's)                -   amitriptyline (Elavil, Endep)                -   clomipramine (Anafranil), also a SSRI                -   desipramine (Norpramin)                -   doxepin (Sinequan)                -   imipramine (Tofranil)                -   maprotiline (Ludiomil)                -   nortriptytine (Aventyl, Pamelor)                -   protriptyline (Vivactil)            -   Monoamine oxidase inhibitors (MAO-I's)                -   clorgyline (specific for MAO type A)                -   isocarboxazid (Marplan)                -   phenelzine (Nardil)                -   tranylcypromine (Parnate)            -   Second Generation Medicaments (not including SSRIs)                -   amoxapine (Asendin)                -   bupropion (Wellbutrin)                -   netazodone (Serzone)                -   trazodone (Desyrel)            -   Serotonin-Specific Reuptake Inhibitors (SSRIs)                -   citalopram (Celexa)                -   clomipramine (Anafranil)                -   escitalopram (Lexapro)                -   fluoxetine (Prozac)                -   fluvoxamine (Luvox)                -   paroxetine (Paxil)                -   sertraline (Zoloft)            -   Other                -   lithium                -   mirtazapine (Temeron)                -   venlafaxine (Effexor)        -   Anti-anxiety agents            -   barbiturates            -   benzodiazepines            -   buspirone (Buspar) chloral hydrate            -   doxepin            -   hydroxyzine            -   sedative-hypnotics            -   serotonin reuptake inhibitors        -   Anti-demential Medicaments            -   cholinesterase inhibitors                -   donepezil (Aricept)                -   galantamine (Reminyl)                -   rivastigmine (Exelon)                -   tacrine (Cognex)

Endocrinologic System Disorders

-   -   Diabetes mellitus    -   Thyroid disorders    -   Adrenal Gland disorders    -   Pituitary Gland disorders    -   ACTH    -   Adrenal androgens    -   Adrenocortical Function Antagonists    -   Mineralocorticoid antagonists    -   Anti-Diabetic Medicaments        -   Insulin        -   Sulfonylureas            -   acetohexamide (Dymelor)            -   chlorpropamide (Diabinese)            -   glimepiride (Amaryl)            -   glipizide (Glucotrol)            -   glyburide (Micronase, DiaBeta)            -   tolazamide (Tolinase)            -   tolbutamide (Orinase)        -   Biguanides            -   metformin (Glucophage)        -   Alpha-glucosidase Inhibitors            -   acarbose (Precose)            -   miglitol (Glyset)        -   Thiazolidinedione Derivatives            -   pioglitazone (Actos)            -   rosiglitazone (Avandia)            -   troglitazone (Rezulin)    -   Thyroid Disorder Medicaments        -   Levothyroxine        -   Liothyronine        -   Liotrix    -   Hypothalamic and Pituitary Gland Medicaments        -   bromrocriptine (Parlodel)        -   chorionic gonadotropin (hCG)        -   corticotropin generic (ACTH)        -   cosyntropin (Cortrosyn)        -   desmopressin (DDAVP)        -   gonadorelin acetate (GnRH) (Lutrepulse)        -   gonadorelin hydrochloride (GnRH) (Factrel)        -   goserelin acetate (Zoladex)        -   growth hormone        -   histrelin (Supprelin)        -   leuprolide (Lupron)        -   menotropins (hMG) (Pergonal, Humegon)        -   natarelin (Synarel)        -   octreotide (Sandostatin)        -   oxytocin (Pitocinit, Syntocinon)        -   pergolide (Permax)        -   protirelin (Thypinone, Relefact TRH)        -   sermorelin (GHRH) (Geref)        -   somatrem (Protropin)        -   somatropin (Humatrope, Nutropin)        -   thyrotropin (TSH) (Thytropar)        -   urofollitropin (Metrodin)        -   vasopressin (Pitressin Synthetic)

Gynecologic System and Obstetric Conditions

-   -   Pregnancy and Lactation    -   Infertility    -   Contraception    -   Menstruation-related disorders    -   Endometriosis    -   Hormone Replacement Therapy (HRT)    -   Conjugated estrogens (Premarin)    -   desogestrel    -   di-norgestrel    -   ethinyl diacetate    -   ethinyl estradiol    -   levonorgestrel    -   medroxyprogesterone    -   norethindrone norgestimate    -   progesterone

Urologic System Disorders

-   -   Erectile Dysfunction    -   Benign Prostatic Hypertrophy    -   Urinary Incontinence    -   apomorphine    -   alprostadit    -   phosphodiesterase (PDE-5) inhibitors        -   sildenafil (Viagra)        -   tadalafil (Cialis)        -   vardenafil (Levitra)    -   tolterodine (Detrol)    -   tamulosin (Flomax)    -   yohimbine

Immunologic System Disorders

-   -   Systemic Lupus Erythematosus and other Collagen-vascular        diseases    -   Allergic and pseudo-allergic drug reactions

Bone and Joint System Disorders

-   -   Osteoporosis and Osteomalacia    -   Rheumatoid Arthritis    -   Osteoarthritis    -   Gout and hyperuricemia    -   Medicaments used in the Control of Inflammation        -   Non-steroidal anti-inflammatory drugs (NSAIDs)            -   aspirin        -   diclofenac (Cataflam, Voltaren)        -   diflusnisal (Dolobid)        -   etodolac (Lodine)        -   fenoprofen (Nalfon)        -   flubiprofen (Ansaid)        -   ibuprofen (Motrin, Advil, Nuprin)        -   indomethacin (Indocin)        -   ketoprofen (Orudis)        -   ketorolac (Toradol)        -   meclofenamate        -   nabumetone (Relafen)        -   naproxen (Naprosyn)        -   oxaprozin (Daypro)        -   phenylbutazone        -   piroxicam (Feldene)        -   salicytate        -   sulindac (Clinoril)        -   tolmetin (Tolectin)    -   Cycloexygenase-2 inhibitors (COX-2)        -   celecoxib (Celebrex)        -   rofecoxib (Vioxx)    -   Arthritis and Gout Medicaments        -   allopurinol        -   anti-malarial compounds            -   chloroquine        -   colchicine        -   enbrel        -   Glucocorticoids        -   Gold        -   methotrexate        -   NSAIDs        -   Penicillamine    -   Other Medicaments        -   alendronate (Fosamax)        -   raloxifene (Evista)

Disorders of the Eyes, Ears, Nose, and Throat Systems

-   -   Glaucoma    -   Allergic rhinitis        -   Histamine-1 receptor antagonists            -   brompheniramine (Dimetane)            -   cetirizine (Zyrtec)            -   chlorpheniramine (Chlor-Trimeton)            -   clemastine (Tavist)            -   cyproheptadine (Periactin)            -   dimenhydrinate (Dramamine)            -   diphenhydramine (Bendaryl)            -   doxylamine (Sominex, Unisom)            -   fexofenadine (Allegra)            -   loratidine (Claritin)        -   Sympathomimetic medicaments            -   pseudoephedrine (Sudafed)

Dermatologic System Disorders

-   -   Acne    -   Psoriasis    -   Rosacea and pigmentation disorders

Hematologic System Disorders

-   -   Hematopoeisis    -   Anemias    -   Coagulation disorders    -   Sickle-cell anemia        Drug-induced hematologic disorders    -   Coagulation disorders Medicaments        -   aspirin        -   clopidogrel (Plavix)        -   fibrinolytic inhibitors        -   fibrinolytics        -   glycoprotein (OP) IIb/IIIa antagonists/monoclonal antibodies            -   abciximab (Reopro)            -   eptifibatide (Integrelin)            -   tiofibran (Aggrastat)        -   heparin        -   low-molecular weight heparins        -   Plasma fractions—blood factors        -   ticlopidine (Ticlid)        -   vitamin K        -   warfarin (Coumadin)

Infectious System Diseases

-   -   Central Nervous System (CNS) infections    -   Lower Respiratory Tract infections    -   Upper Respiratory Tract Infections    -   Skin and Soft Tissue Infections    -   Infective Endocarditis    -   Tuberculosis    -   Gastrointestinal Infections and Enterotoxigenic poisonings    -   Intra-abdominal Infections    -   Parasitic diseases    -   Urinary Tract Infections and Prostatis    -   Sexually Transmitted Diseases    -   Bone and Joint Infections    -   Sepsis and Septic Shock    -   Superficial Fungal Infections    -   Invasive Fungal Infections    -   Infections in Inunmocompromised Patients    -   Antimicrobial prophylaxis in Surgery    -   Vaccines, toxoids, and other immunobiologics    -   Human Immunodeficiency Virus Infection    -   Medicaments used in Infectious diseases    -   Cell Wall Synthesis Inhibitors        -   Penicillins        -   amoxicillin (Amoxil Polymox)        -   ampicillin (Principen, Omnipen)        -   benzathine Penicillin G        -   benzyl Penicillin (Penicillin G)        -   carbenicillin (Geocillin)        -   cloxacillin (Cloxapen)        -   dicloxacillin (Dynapen)        -   methicillin (Staphcillin)        -   mezlocillin        -   nafcillin (Nafcil, Unipen)        -   oxacillin        -   phenoxymethyl Penicillin (Penicillin V)        -   piperacillin (PipracH)        -   ticarcillin (Ticar)    -   Cephalosporins        -   1st generation:            -   cefazolin (Ancef, Defzol)            -   cephalexin (Keflex)            -   cephatothin (Keflin)        -   2nd generation:            -   cefaclor (Ceclor)            -   cefoxitin (Mefoxin)            -   cefpodoxime (Vantin)            -   cefuroxime (Zinacef, Ceftin)            -   loracarbef (Lorabid)        -   3rd generation:            -   cefoperazone            -   cefotaxime (Claforan)            -   cefotetan            -   ceftazidime (Fortax, Taxidime, Tazicef)            -   ceftriaxone (Rocephin)            -   veftizoxime (Cefizox)        -   4th generation:            -   cefepime    -   Other beta-Lactans aztreonam (Azactan)        -   clavulanic acid        -   imipenem (Primaxin)        -   meropenem (Merrem IV)        -   sulbactam    -   Other Cell-Wall Synthesis Inhibitors bacitracin        -   cycloserine        -   fosfomycin (Monurol)        -   vancomycin (Vancocin)    -   Agents Which Affect Cell Membranes        -   Polymixins            -   Colistimethate            -   Potymyxin B    -   Protein Synthesis Inhibitors        -   Aminoglycosides            -   amikacin (Amikin)            -   gentamicin (Garamycin)            -   kanamycin (Kantrex)            -   neomycin            -   netilmicin (Netromycin)            -   streptomycin            -   tobramycin        -   Tetracyclines            -   demeclocycline (Declomycin)            -   doxycycline            -   doxycyclmne (Vibramycin, Doryx)            -   tetracycline (Achromycin)        -   Macrolides            -   azithromycin (Zithromax)            -   clarithromycin (Biaxin)            -   erythromycin esters erythromycin        -   Other Protein Synthesis Inhibitors            -   Chloramphenicol (Chloromycetin)            -   Clindamycin (Cleocin)            -   Spectinomycin (Trobicin)        -   Inhibitors of Folate-Dependent Pathways            -   co-trimoxazole            -   silver Sulfadiazine            -   sodium Sulfacetamide            -   sulfamethoxazole (Gantanol)            -   sulfasalazine (Azulfidine) (Salicylazosulfapyridine)            -   sulfisoxazole (Gantrisin)            -   sulfonamides        -   Dihydrofolate Reductase Inhibitor            -   trimethoprim        -   DNA Gyrase Inhibitors            -   ciprofloxacin (Cipro)            -   gatifloxacin (Tequin)            -   levofloxacin (Levaquin)            -   lomefloxacin (Maxaquin)            -   nalidixic acid            -   ofloxacin (Floxin)        -   Urinary Tract Antiseptics            -   nitrolurantoin        -   Antimyobacterial Agents            -   First-line anti-TB medicaments                -   ethambutol                -   isoniazid (INI-I)                -   pyrazinamide                -   rifampin (Rimactane)                -   streptomycin            -   Second-line anti-TB medicaments                -   capreomycinA                -   cycloserine                -   dapsone                -   ethionamide                -   para-aminosalicylic acid        -   AntiFungal Agents            -   amphotericin B (Fungizone, Amphotec)            -   clotrimazole (Mycelex)            -   fluconazole (Diflucan)            -   flucytosine            -   griseofuivin            -   itraconazole (Sporanox)            -   ketoconazole (Nizoral)            -   miconazole (Monistat)            -   nystatin (Mycostatin)        -   AntiParasitic Agents        -   Antimalarials            -   chloroquine (Aralen)            -   mefloquine (Lariam)            -   primaquine            -   pyrimethamine-sulfadoxine (Fansidar)        -   Anti protozoals            -   metronidazole (Flagyl)            -   pentamidine isethionate            -   pyrimethamine-sulfonamide            -   trimethoprim (generic) sulfamethoxazole (Gantanol)        -   Antihelminthic Medicaments            -   mebendazole            -   praziquantel (Biltricide)            -   pyrantel pamoate            -   thiabendazole (Mintezol)        -   Antiviral Medicaments            -   acyclovir (Zovirax)            -   didanosine (DDI)            -   foscarnet (Foscavir)            -   ganciclovir (DHPG, Cytovene)            -   ribavirin            -   rimantadine            -   stavudine (d4T))            -   valacyclovir (Valtrex)            -   vidarabine (Vira-A)            -   zalcitabine (ddC)            -   zidovudine (Azidothymidine, AZT)        -   Protease inhibitors            -   indinavir (Crixivan)            -   ritonavir (Norvir)            -   saquinavir (Fortovase)

Oncologic and Immunological Disorders

-   -   Breast Cancer    -   Lung Cancer    -   Colorectal Cancer    -   Prostate Cancer    -   Malignant Lymphomas    -   Ovarian Cancer    -   Acute Leukemias    -   Chronic Leukemias    -   Melanoma and other Skin Cancers    -   Hematopoeitic Stem Cell Transplantation    -   Anti-neoplastic Medicaments        -   Alkylating Agents            -   busulfan (Myleran)            -   carboplatin (Paraplatin)            -   carmustine (BNCU, BiCNU)            -   cisplatin (Platinol)            -   cyclophosphamide (Cytoxan)            -   ifofamide (Ifex)            -   lomustine (CCNJ, CeeNU)            -   mechlorethamine (Mustargen)            -   meiphalan (Alkeran)            -   procarbazine (Matulane)            -   thiotepa        -   Antimetabolites            -   folic acid Antagonist            -   methotrexate        -   Purine Antagonists 6-mercaptopurine            -   6-thioguanine        -   Pyrimidine Antagonists            -   cytarabine (ARA-C)            -   fluorouracil (5-FU)        -   Hormonal Agents Hormones            -   diethylstilbestrol (DES)            -   estrogens            -   prednisone (Deltasone)        -   Modulation of Hormone Release & Action Aminoglutethimide            -   leuprolide acetate            -   tamoxifen (Nolvadex)        -   Plant Alkaloids            -   Vinca Alkaloids                -   vinblastine (Velban)                -   vincristine (Oncovin)            -   Podophyllotoxins                -   Etoposide (VP-16)            -   Other                -   docetaxel (Taxotere)                -   paclitaxel (Taxol)        -   Antibiotics            -   bleomycin (Blenoxane)            -   dactinomycin (Cosmegen)            -   daunorubicin (DaunoXome)            -   doxorubicin (Adriamycin)            -   mitomycin (Mutamycin)        -   Other Anti-neoplastic Medicaments            -   amsacrine (AMSA)            -   azathioprine (Imuran)            -   capecitabine (Xeloda)            -   chlorambucil (Leukeran)            -   cyclosporine (Sandimmune, Neoral)            -   gemcitabine (Gemzar)            -   hydroxyurea (Hydrea)            -   mitotane (Sodren)            -   mitoxantrone (Novantrone)            -   pamidronate (Aredia)    -   Immunosuppressant Medicaments        -   15-desoxyspergualin        -   corticosteroids        -   cyclosporine        -   Interferons        -   Interleukins        -   mycophenolate mofetil        -   sirolimus (rapamycin)        -   tacrolimus        -   thalidomide

Nutritional Disorders

-   -   Malnutrition, vitamin and mineral deficiencies    -   Enteral Nutrition    -   Obesity        -   orlistat (Xenical)        -   appetite suppressants        -   sympathomimetic stimulants        -   amphetamine stimulants    -   Mineral supplementation        -   calcium ion iodine        -   iron        -   magnesium ion        -   phosphorous        -   potassium ion        -   selenium        -   sodium ion        -   zinc    -   Fat-soluble vitamins        -   vitamin A        -   vitamin D        -   vitamin E        -   vitamin K    -   Water-soluble vitamins        -   vitamin C        -   thiamine (vitamin B1)        -   riboflavin (vitamin B2)        -   niacin (vitamin B3)        -   pyridoxine (vitamin B6)        -   folate        -   cyanocobalamin (vitamin B12)

Medicaments Used to Alleviate Symptoms of Allergic Rhinitis, UpperRespiratory Symptoms, Cough, Mild Aches and Pains

-   -   Nasal Decongestants        -   ephedrine        -   phenylephrine        -   phenylpropanolamine        -   pseudoephedrine    -   Antihistamines (Histamine-1 receptor antagonists)    -   Antitussive agents        -   benzonatate        -   codeine        -   dextromethorphan    -   Expectorants        -   guaifenesin        -   iodinated glycerol        -   terpin hydrate    -   Xanthines        -   aminophylline        -   caffeine        -   dyphylline        -   theophylline    -   Pain relievers        -   narcotic agonists        -   NSAIDS        -   acetaminophen

Dietary Supplements

-   -   Arnica    -   Bilberry    -   Black Cohosh    -   Cat's claw    -   Chamomile    -   Echinacea    -   Evening Primrose Oil    -   Fenugreek    -   Flaxseed    -   Feverfew    -   Garlic    -   Ginger root    -   Ginkobiloba    -   Ginseng    -   Goldenrod    -   Hawthorn    -   Kava-Kava    -   Licorice    -   Milk thistle    -   Psyllium    -   Rauwolfia    -   Senna    -   Soybean    -   St. John's wort    -   Saw palmetto    -   Turmeric    -   Valerian

Therapeutic Proteins and Biotechnology Medicaments

Additional Agents

-   -   Norvase, Neurontin, Paxil, Augmentin, Propecia, Lamisil, Lescol,        bisphosphonate.

Other Drugs

-   -   abacavir sulfate    -   acetazolamide    -   acetylsalicylic acid    -   albendazole    -   allopurinol    -   amiloride hydrochloride    -   amitriptyline hydrochloride artemether    -   atropine sulfate    -   benznidazole    -   biperiden hydrochloride    -   chloroquine phosphate    -   chlorpheniramine maleate    -   chlorpromazine hydrochloride    -   cimetidine    -   ciprofloxacin hydrochloride    -   clofazimine    -   clomiphene citrate    -   clomipramine hydrochloride    -   cloxacillin sodium    -   codeine phosphate    -   dapsone    -   didanosine    -   diethylcarbamazine citrate    -   digoxin    -   diloxanide furoate    -   DL-methionine    -   Doxycycline    -   Efavirenz    -   ergometrine maleate    -   ergotamine tartrate    -   erythromycin ethyl succinate    -   ethambutol hydrochloride    -   ethosuximide    -   ferrous sulfate    -   alendronate sodium    -   amlodipine besylate    -   amphetamine (mixed salts)    -   atorvastatin calcium    -   benazepril hydrochloride    -   bisoprolol fumarate    -   bupropion hydrochloride    -   carbidopa    -   cefprozil    -   cetirizine hydrochloride    -   citalopram hydrobromide    -   clindamycin hydrochloride    -   clonidine hydrochloride    -   clopidogrel bisulfate    -   cyclobenzaprine hydrochloride    -   desloratadine    -   digoxin    -   diltiazem hydrochloride    -   doxazosin mesylate    -   doxycycline    -   enalapril maleate    -   fexofenadine hydrochloride    -   fluoxetine hydrochloride    -   folic acid    -   fosinopril sodium    -   hydrocodone bitartrate    -   hydrocodone    -   hydroxyzine hydrochloride    -   indinavir    -   irbesartan    -   isosorbide mononitrate    -   lamivudine    -   levothyroxine sodium    -   lopinavir    -   loratadine    -   losartan potassium    -   meclizine hydrochloride    -   medroxyprogesterone acetate    -   meperidine    -   metformin hydrochloride    -   methylphenidate hydrochloride    -   methylprednisolone    -   metoclopramide hydrochloride)    -   minocycline hydrochloride    -   montelukast sodium    -   naproxen sodium    -   nelfinavir    -   nevirapine    -   niclosamide    -   nicotinamide    -   nifurtimox    -   nitrofurantoin    -   nortriptyline hydrochloride    -   oxybutynin chloride    -   oxycodone hydrochloride    -   paracetamol    -   paroxetine hydrochloride    -   penicillin V potassium    -   phenyloin sodium    -   pioglitazone hydrochloride    -   prednisolone    -   primaquine phosphate    -   pravastatin sodium    -   prednisolone    -   promethazine hydrochloride    -   promethazine fumarate    -   propylthiouracil    -   pyrantel embonate    -   pyridostigmine bromide    -   raloxifene hydrochloride    -   ranitidine hydrochloride    -   rifampicin    -   risedronate sodium    -   risperidone    -   rosiglitazone maleate    -   salbutanmol sulfate    -   saquinavir mesylate    -   sertraline hydrochloride    -   sildenafil citrate    -   sulfadiazine    -   sumatriptan succinate    -   tamoxifen citrate    -   tamsulosin hydrochloride    -   temazepam    -   terazosin hydrochloride    -   timolol maleate    -   tolterodine tartrate    -   tramadol hydrochloride    -   trazodone hydrochloride    -   triclabendazole    -   valacyclovir hydrochloride    -   valdecoxib    -   valproic acid    -   valsartan    -   venlafaxine hydrochloride    -   verapamil hydrochloride    -   warfarin sodium    -   zolpidem tartrate

Examples XII

As can be seen above, various embodiments of the present invention canbe utilized in specific medical applications. By way of example only andnot by way of limitation, the present invention can be practiced toprepare delivery devices for use in chemotherapy to address/treat, byway of example and not by limitation, the following aspects ofchemotherapy: psychological, timing (to coincide with tumor growth forexample) route of administration, nausea, vomiting (CINV), compliance,and cost (e.g. reduce hospital management of patients, reduce the numberof “repeat” drug doses due to patient vomiting, etc.). Still further,the just mentioned aspects are not limited to chemotherapy, as thepresent invention can be practiced to address common aspects betweenchemotherapy and other treatments.

Further by way of examples, capsules containing Zofran (ondansertron),Temodar (temozolomide) can be made.

Still further, the present invention can be used in cardiovasculartreatments, for example hypertension, heart failure, and heart rhythmdisorders. Also, the present invention can be used in immunology (e.g.transplant rejections, auto-immune disorders, etc.). The presentinvention can be used to treat neurological disorders (such asParkinson's disease, dementia, stroke, epilepsy, and migraine headache,etc.), psychiatric disorders (schizophrenia, bipolar disease,depression, anxiety, ADHD/ADD, Addictions, etc.), infectious diseases(fungal, bacterial, viral (HIV), etc.), and in anesthesiology (inductionanesthesia, local anesthesia). Furthermore, the present invention hasapplication in endocrinology (cholesterol, diabetes, hormone replacementtherapy, thyroid dysfunction, oral contraception, obesity, etc.),dermatology (onychomycosis, acne, rosaceae, psoriasis, etc.),rheumatology (arthritis, gout, osteoporosis/Osteomalacia), respiratoryfields (asthma, emphysema, cystic fibrosis, etc.), gastro-intestinalfields (gastro-esophageal reflux disease, ulcer prophylaxis, crohn'sdisease, inflammatory bowel disease, etc.), chronic renal failure(vitamin and mineral replacement, blood pressure regulation, diabetes,depression, etc.), genito-urinary (enlarged prostate/BPH, overactivebladder, erectile dysfunction, feminine yeast infections, etc.) andhematology-oncology (thromboembolous, hermatopoeisis, neoplasticdisease, nausea/vomiting).

Examples XIII

The present invention can be utilized with a variety of excipients.Categories of excipients include, but are not limited to, Binders,Disintegrants Fillers (diluents), Lubricants, Glidants (flow enhancers),Compression aids, Colors, Sweeteners, Preservatives,Suspensing/dispersing agents, Film formers/coatings, Flavors, andPrinting inks. Still further by way of example and not by limitation,the present invention can be utilized with the following excipients:

Magnesium Stearate Calcium Stearate Lactose Povidone MicrocrystallineCellulose Pregelatinized Starch Starch (corn) Hydroxy PropylMethylcellulose Silicon Dioxide OPA products (coatings & inks) TitaniumDioxide Croscarmellose Stearic Acid Hydroxy Propyl Cellulose SodiumStarch Glycolate Ethylcellulose Gelatin Calcium Phosphate (dibasic) TalcCrospovidone Sucrose Shellac (and Glaze)

Examples XIV

Examples of the supporting nutraceutical formulations are to illustrateexamples where specific categories of the natural products industry canbe utilized with the present invention. There are many more categoriesthan the ones that are listed and therefore this is for simply for thepurpose to show that the technology is broad and could be utilized formany specific categories. The specific mg of each product is notincluded due to the amounts of each material is typically based upon theformulators opinions, however there are some (RDA) recommended dailyallowances that could be used to determine the formulation,

Category: Antioxidant

Primary Capsule:

-   -   d alpha Tocopherol    -   Beta Carotene    -   Tocotrineol    -   Grape Seed Oil

Secondary Capsule:

-   -   Selenium    -   Vitamin C Ester

Category: Brain Support Primary Capsule:

d alpha Tocopherol

DHA

Omega 3

Lecithin

Choline

Secondary Capsule:

Coenzyme Q 10

Ginkgo Biloba

B 12

Category: Mood Support

Primary Capsule:

D alpha Tocopherol

Lecithin

DNA

Omega 3

Secondary Capsule:

SAME

L Tyrosine

Category: Cardio Support Primary Capsule:

d alpha Tocopherol

Tocotrienol

Flax Oil Omega 6

Fish Oil Omega 3

Secondary Capsule:

Calcium

Magnesium

Coenzyme Q 10

Category: Diet Support Primary Capsule:

Cojugated Linolic Acid

Flax Seed Oil

Secondary Capsule:

Chromium

Zinc

L Carnitine

Category: Immune Support Primary Capsule:

Garlic Oil

Olive Leaf Oil

d alpha Tocopherol

Secondary Capsule:

Zinc

Echinacea

Category Laxative Support Primary Capsule:

Aloe Vera

Flax Seed Oil

Secondary Capsule:

Senna Leaf

Psyllium

Category: Prostate Support Primary Capsule:

Saw Palmetto Oil

Pygeum Oil

Flaxseed Oil

Pumpkin Seed Oil

Secondary Capsule:

Selenium

Zinc

Boswellia Serrata

Category: Inflammation Support Primary Capsule:

Boswellia Serrata Oil

Guggul Oil

Omega 3 Oil

Ginger Oil

Secondary Capsule:

Curcumin

Holy Basil

Category: Sports Nutrition/Muscle Support Primary Capsule:

Cojugated Linolic Acid

MCT Oil

Secondary Capsule:

Zinc

Chromium

Tribulus Terrestris

19 Nor-5-Androstendione

Category: Menopause Support Primary Capsule:

Evening Primrose Oil

Red Raspberry Oil

Secondary Capsule:

Licorice Root

Black Cohosh

Soy Isoflavones

Category: Cholesterol Support Primary Capsule:

Sterol Esters

Guggul Oil

d alpha Tocopherol

Tocotrienol

Secondary Capsule:

Garlic Extract

Zinc

From the above discussion, it will be appreciated that the presentinvention provides novel integrated capsule delivery apparatus andmethods for delivering diverse physical states (e.g., solid, liquid, gasor dispersion) of a single active ingredient or medicament (e.g.,pharmaceutical, biotechnical, nutraceutical, vitamin, dietarysupplement, mineral or combination thereof), or a plurality of activeingredients or medicaments, in a single dosage capsular form, wherein atleast two of the active ingredients or medicaments if differentreceiving chambers have physical states that differ. In preferreddesign, the encapsulation processes and multi-compartment capsulartechnology of the present invention may include various desirableproperties such as, for example, controlling time-release of key activeingredients or medicaments, prolonging shelf-life of the activeingredients or medicaments, improving palatability, reducing overallproduction costs and reducing the number of capsules consumed by apatient or consumer as nutritional or therapeutic agents.

The present invention provides novel integrated capsule deliveryapparatus and methods for delivering a single dosage, multi-compartmentcapsule comprising a capsular base and cap configuration, wherein thesize and shape of the cap, relative to its sealing relationship with thebase, generally eliminates or substantially reduces any potential deadspace volume within the internal periphery of the capsule, therebyfunctionally negating the opportunity for reaction between an air bubbleand one or more active ingredients introduced into the capsule and,accordingly, improving stability of the capsular ingredient(s).

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrative,and not restrictive. The scope of the invention is, therefore, indicatedby the appended claims, rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

1. A multi-compartment capsule, comprising: a first receiving chambercomprising at least one ingredient having a first physical state,wherein said ingredient is selected from the group consisting of anutraceutical, a vitamin, a dietary supplement and a mineral; and asecond receiving chamber comprising at least one ingredient having asecond physical state, wherein said ingredient is selected from thegroup consisting of a nutraceutical, a vitamin, a dietary supplement anda mineral; wherein said first physical state of said ingredient of saidfirst receiving chamber being different from said second physical stateof said ingredient of said second receiving chamber; and said ingredientof said first receiving chamber being different from said ingredient ofsaid second receiving chamber. 2-118. (canceled)